(133 days)
Not Found
No
The summary describes a mechanical spinal stabilization system with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device is a system of implants (rods, screws, hooks) for spinal stabilization and fusion, which is a therapeutic intervention for various spinal conditions.
No
The CREO™ Stabilization System is a spinal fixation device intended for surgical use as an adjunct to fusion for treating various spinal conditions, such as degenerative disc disease, trauma, and deformities. It consists of implants like rods, screws, and hooks that are physically attached to the spine to provide stabilization, not to diagnose medical conditions.
No
The device description clearly outlines physical implants (rods, hooks, screws, etc.) made of various metal alloys, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the CREO™ Stabilization System consists of implants (rods, screws, hooks, etc.) intended for surgical implantation into the spine for fixation and stabilization. This is an in vivo (within the living body) application, not an in vitro test.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, reagents, or laboratory procedures, which are characteristic of IVD devices.
Therefore, the CREO™ Stabilization System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CREO™ Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients (CREO™ 4.75 only). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO Stabilization System is intended to be used with autograft and/or allograft.
In addition, the CREO™ Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO™ 4.75 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The CREO™ 4.75 Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
In order to achieve additional levels of fixation in skeletally mature patients, the CREO™ Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod), REVERE® 4.5 Stabilization System (4.5mm rod) or ÉLLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. In order to achieve additional levels of fixation in pediatric patients, the CREO™ Stabilization System rods may be connected to the REVERE® 4.5 Stabilization System using corresponding connectors. Refer to the REVERE®, REVERE® 4.5, or ELLIPSE® system package insert for instructions and indications of use.
Product codes (comma separated list FDA assigned to the subject device)
NKB, OSH, MNI, MNH, KWP, KWQ
Device Description
The CREO™ Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking caps, t-connectors, head offset connectors, trans-iliac connectors, staples, and associated manual surgical instruments. Implants are available in a variety of sizes to accommodate individual patient anatomy. CREO™ implants mate with 4.75mm, 5.5mm, and 6.35mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and t-connectors are intended for posterior use only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod and trans iliac connectors.
The most common use of this screw, hook, and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws and/or lamina, pedicle or transverse process hooks.
The most common use of this screw, hook, and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.
Screws and hooks attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine. Screws may be used with a staple. The type and number of hooks are also dependent on the location in the spine needing correction and/or stabilization. Hooks are attached to the laminae, pedicles, or transverse process of the posterior spine.
T-connectors are modular components designed to connect the two rods of a construct and act as a structural cross member. The rod-clamping set screws secure the tconnectors to the rods. Additional set screws secure the adjustable cross members at the desired length. Additional connectors may be used to connect two rods, and are also secured using set screws.
CREO™ Stabilization System S-rods and unit rods are specifically excluded for use in adolescent idiopathic scoliosis patients.
The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F67, F1537 and F138. All other CREO™ implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295, F67 and F138. Screws are also available with hydroxyapatite (HA) coating per ASTM F1185. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium-molybdenum alloy implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal, posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), anterolateral fixation (T8-L5), L5-S1 vertebra, lumbosacral spine, ilium
Indicated Patient Age Range
skeletally mature patients (including small stature), pediatric patients (CREO™ 4.75 only), adolescent idiopathic scoliosis patients (excluded for S-Rods and Unit Rods), skeletally mature patients (for severe spondylolisthesis), pediatric patients (for adolescent idiopathic scoliosis)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing (static and dynamic compression, and static torsion) was conducted in accordance with ASTM F1717 and the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
REVERE® Stabilization System K122226, REVERE® 4.5 Stabilization System K113395, Medtronic CD Horizon® Spinal System K102807, Synthes USS (including Matrix and Click'X) Spinal System.K031175, K100952 & K103287, DePuy VIPER® 2 System K111136
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
510(k) Summary: CREO™ Stabilization System
MAY 1 3 2013
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sarah Marie Fitzgerald
Project Manager, Regulatory Affairs |
| Date Prepared: | May 3, 2013 |
| Device Name: | CREO™ Stabilization System |
| Classification: | Per 21 CFR as follows:
§888.3050 Spinal Interlaminal Fixation Orthosis
§888.3060 Spinal Intervertebral Body Fixation Orthosis
§888.3070 Pedicle Screw Spinal System
§888.3070 Spondylolisthesis Spinal Fixation Device System
§888.3070 Pedicle Screw Spinal System, Adolescent Idiopathic
Scoliosis
Product Codes MNH, MNI, KWQ, KWP, NKB, OSH
Regulatory Class II and III, Panel Code 87. |
| Predicate(s): | REVERE® Stabilization System K122226
REVERE® 4.5 Stabilization System K113395
Medtronic CD Horizon® Spinal System K102807
Synthes USS (including Matrix and Click'X) Spinal System.
K031175, K100952 & K103287
DePuy VIPER® 2 System K111136 |
Purpose:
The purpose of this submission is to request clearance of the CREO™ Stablization System.
Device Description:
The CREO™ Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking caps, t-connectors, head offset connectors, trans-iliac connectors, staples, and associated manual surgical instruments. Implants are available in a variety of sizes to accommodate individual patient anatomy. CREO™ implants mate with 4.75mm, 5.5mm, and 6.35mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and t-connectors are intended for posterior use only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod and trans iliac connectors.
1
The most common use of this screw, hook, and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws and/or lamina, pedicle or transverse process hooks.
The most common use of this screw, hook, and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.
Screws and hooks attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine. Screws may be used with a staple. The type and number of hooks are also dependent on the location in the spine needing correction and/or stabilization. Hooks are attached to the laminae, pedicles, or transverse process of the posterior spine.
T-connectors are modular components designed to connect the two rods of a construct and act as a structural cross member. The rod-clamping set screws secure the tconnectors to the rods. Additional set screws secure the adjustable cross members at the desired length. Additional connectors may be used to connect two rods, and are also secured using set screws.
CREO™ Stabilization System S-rods and unit rods are specifically excluded for use in adolescent idiopathic scoliosis patients.
The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F67, F1537 and F138. All other CREO™ implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295, F67 and F138. Screws are also available with hydroxyapatite (HA) coating per ASTM F1185. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium-molybdenum alloy implants.
Indications for Use:
The CREO™ Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients (CREO™ 4.75 only). These devices are indicated as an adjunct to fusion for all of the following indications: deqenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis. Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO Stabilization System is intended to be used with autograft and/or allograft.
2
In addition, the CREO™ Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO™ 4.75 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The CREO™ 4.75 Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
In order to achieve additional levels of fixation in skeletally mature patients, the CREO™ Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod), REVERE® 4.5 Stabilization System (4.5mm rod) or ÉLLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. In order to achieve additional levels of fixation in pediatric patients, the CREO™ Stabilization System rods may be connected to the REVERE® 4.5 Stabilization System using corresponding connectors. Refer to the REVERE®, REVERE® 4.5, or ELLIPSE® system package insert for instructions and indications of use.
Performance Data:
Mechanical testing (static and dynamic compression, and static torsion) was conducted in accordance with ASTM F1717 and the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device.
Conclusions / Basis of Substantial Equivalence:
The CREO™ Stabilization System implants are similar to the predicate implants with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices. CREO™ implants are as safe, as effective, and perform as well as or better than the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: May 13, 2013
Globus Medical, Incorporated % Ms. Sarah M. Fitzgerald Project Manager, Regulatory Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K124058
Trade/Device Name: CREOTM Stabilization System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNI, MNH, KWP, KWQ Dated: April 19, 2013 Received: April 22, 2013
Dear Ms. Fitzgerald:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Sarah M. Fitzgerald
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark Nijierson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
K124058 510(k) Number:
CREO™ Stabilization System Device Name:
INDICATIONS:
The CREO™ Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients (CREO™ 4.75 only). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO Stabilization System is intended to be used with autograft and/or allograft.
In addition, the CREO™ Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO™ 4.75 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The CREO™ 4.75 Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
In order to achieve additional levels of fixation in skeletally mature patients, the CREO™ Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod), REVERE® 4.5 Stabilization System (4.5mm rod) or ÉLLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. In order to achieve additional levels of fixation in pediatric patients, the CREO™ Stabilization System rods may be connected to the REVERE® 4.5 Stabilization System using corresponding connectors. Refer to the REVERE®, REVERE® 4.5, or ELLIPSE® system package insert for instructions and indications of use.
Over-The-Counter Use OR Prescription Use X (Per 21 CFR §801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
- (Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K124058