(52 days)
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a spinal fixation system intended to treat various spinal conditions like degenerative disc disease, scoliosis, and trauma, which are therapeutic indications as it aims to alleviate symptoms or cure diseases.
No
Explanation: The device is described as a spinal fixation device intended for surgical implantation to provide stabilization, not to diagnose medical conditions.
No
The device description clearly states it is comprised of physical components like screws, rods, and connectors, and the performance studies are bench tests on these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Synthes USS are spinal fixation devices intended for surgical implantation to stabilize the spine. They are used as an adjunct to fusion for various spinal conditions.
- Lack of Mention of Specimens or Analysis: The text does not mention the collection or analysis of any biological specimens. The device is a physical implant.
Therefore, the Synthes USS falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes USS 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 limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. 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 treating patients with Degenerative Disc Disease (DDD). transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.
When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5 mm tapered rods, Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to Synthes USS 5.5 mm rod systems.
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI, KWQ, KWP
Device Description
This is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium). posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). The current system is comprised of monoaxial and polyaxial screws, rods, locking caps, transverse bars and connectors. The new sagittal screw that is the subject of this submission is similar to the already-cleared polyaxial screw and is manufactured of TAN (Titanium-6 Aluminum-7 Niobium Alloy per ASTM F1295 - 05 ). These screws restrict head angulation to the direction parallel to the rod slot (typically the cranial/caudal direction).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal, T1-S2/ilium, T1-L5, T8-L5
Indicated Patient Age Range
skeletally mature patients, small stature and pediatric patients
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)
Bench testing results demonstrate that the Synthes Matrix performs equivalently or superiorly to the above-mentioned predicates in static compression bending, static torsion, and dynamic compression bending (in accordance with ASTM F1717-11a).
Clinical data and conclusions were not needed for this 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.
Synthes USS, K963045, Synthes Click'X, K992739, Synthes Click'X, K031175, Synthes USS Illiosacral and Polyaxial, K082572, Synthes Matrix System, K092929, Synthes Matrix System, K093668, Synthes Matrix System, K100952, Synthes Matrix System, K100634
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.
Synthes USS, K111358, Synthes MIRS, K113044, Synthes USS, K113149, DePuy Expedium (last cleared as K110216), Stryker Xia (last cleared as K092605), Medtronic CD Horizon (last cleared as K113529)
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
.
8 510(k) Summary
Spine
® SYNTHES®
| 510(k) Summary | ||
|---|---|---|
| Name of Firm: | Synthes Spine | |
| 1302 Wrights Lane East | ||
| West Chester, PA 19380 | ||
| 510(k) Contact: | Heather Guerin | |
| Senior Regulatory Affairs Specialist | ||
| Telephone: 610-719-5432 | ||
| Facsimile: 610-719-5102 | ||
| Email: guerin.heather@synthes.com | ||
| Date Prepared: | March 26, 2012 | |
| Trade Name: | Synthes Matrix System | |
| Classification: | 21 CFR 888.3070 -Pedicle screw spinal system | |
| Class III | ||
| Orthopaedic and Rehabilitation Devices Panel | ||
| Product Code: NKB, MNH, MNI, KWQ, KWP | ||
| Predicates: | Synthes USS, K963045 | |
| Synthes Click'X, K992739 | ||
| Synthes Click'X, K031175 | ||
| Synthes USS Illiosacral and Polyaxial, K082572 | ||
| Synthes Matrix System, K092929 | ||
| Synthes Matrix System, K093668 | ||
| Synthes Matrix System, K100952 | ||
| Synthes Matrix System, K100634 | Synthes USS, K111358 | |
| Synthes MIRS, K113044 | ||
| Synthes USS, K113149 | ||
| DePuy Expedium (last cleared as K110216) | ||
| Stryker Xia (last cleared as K092605) | ||
| Medtronic CD Horizon (last cleared as K113529) | ||
| Device | ||
| Description: | This is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/ilium). posterior pedicle | |
| screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral | ||
| fixation (T8-L5). The current system is comprised of monoaxial and | ||
| polyaxial screws, rods, locking caps, transverse bars and connectors. The | ||
| new sagittal screw that is the subject of this submission is similar to the | ||
| already-cleared polyaxial screw and is manufactured of TAN (Titanium-6 | ||
| Aluminum-7 Niobium Alloy per ASTM F1295 - 05 ). These screws restrict | ||
| head angulation to the direction parallel to the rod slot (typically the | ||
| cranial/caudal direction). | ||
| Intended Use/ | ||
| Indications for | ||
| Use: | The Synthes USS 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 limited to | ||
| skeletally mature patients with the exception of the Small Stature USS, | ||
| which includes small stature and pediatric patients. 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 treating patients with Degenerative Disc Disease (DDD). transverse | ||
| 510(k) Summary | ||
| bars are not cleared for use as part of the posterior pedicle screw construct. | ||
| When used with the 3.5 mm/6.0mm parallel connectors, the Synthes USS | ||
| 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In | ||
| addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes | ||
| Small Stature USS can be linked to the CerviFix 3.5mm Systems. When | ||
| used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature | ||
| USS can be linked to the Synthes USS 6.0 mm rod systems. When used | ||
| with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 | ||
| mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. | ||
| 5.5 mm/5.5mm parallel or extension connectors can be used to link all | ||
| Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel | ||
| or extension connectors can be used to link all Synthes USS 6.0 mm rod | ||
| systems to one another. | ||
| When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the | ||
| Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm | ||
| and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and | ||
| 4.0 mm/5.5 mm tapered rods, Synthes USS 5.5 mm rod systems can be | ||
| linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When | ||
| used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod | ||
| systems can be linked to Synthes USS 5.5 mm rod systems. | ||
| In addition, Synthes USS 6.0 mm rod systems can be interchanged with all | ||
| USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt- | ||
| chromium-molybdenum alloy and titanium grade 3 rods, which can only be | ||
| used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged | ||
| with all USS 5.5 mm rods and transconnectors. | ||
| Synthes USS | ||
| 6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS | ||
| VAS variable axis components, USS Fracture, Click'X, Click'X | ||
| Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, | ||
| ClampFix | ||
| 5.5 mm Rod System: Matrix, MIRS | ||
| 5.0 mm Rod System: USS Small Stature | ||
| CerviFix | ||
| 3.5 mm Rod Systems: CerviFix, Axon, Synapse | ||
| 4.0 mm Rod System: Synapse | ||
| Comparison of | ||
| the device to | ||
| predicate | ||
| device(s): | Synthes Matrix is substantially equivalent to the above-mentioned | |
| predicates in design, function, material and intended use. | ||
| Performance | ||
| Data | ||
| (Non-Clinical | ||
| and/or Clinical): | Non-Clinical Performance and Conclusions: | |
| Bench testing results demonstrate that the Synthes Matrix performs | ||
| equivalently or superiorly to the above-mentioned predicates in static | ||
| compression bending, static torsion, and dynamic compression bending (in | ||
| accordance with ASTM F1717-11a). | ||
| Clinical Performance and Conclusions: | ||
| Clinical data and conclusions were not needed for this device. |
1
® SYNTHES* Spine
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the emblem. The text is in all caps and appears to be in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes Spine % Heather Guerin, Ph.D. Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K120928
Trade/Device Name: Synthes Matrix System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWQ, KWP Dated: March 26, 2012 Received: March 27, 2012
MAY 18 2012
Dear Dr. Guerin:
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 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.
3
Page 2 - Heather Guerin, Ph.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
@ SYNTHES® Spine
7 Indications for Use Statement
510(k) Number: K120928 Device Name: Synthes Matrix System
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/ilium), posterior hook fixation (TI-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. 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 treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.
When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5 mm tapered rods, Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to Synthes USS 5.5 mm rod systems.
Prescription Use X (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE . IF NEEDED)
Col. O'Neill for RPJ
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Division of Surgical. Orthupedic, and Restorative Devices
5
@ SYNTHES * Spine
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.
Synthes USS
- 0 6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
- 5.5 mm Rod System: Matrix, MIRS o
- 5.0 mm Rod System: USS Small Stature 0
CerviFix
- 3.5 mm Rod Systems: CerviFix, Axon, Synapse O
- 4.0 mm Rod System: Synapse 0
Prescription Use X (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Colin O'Neill for RPS
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120928
K120928 Page 2/2