(309 days)
K 091442
None
No
The 510(k) summary describes a mechanical pedicle screw system and does not mention any AI or ML components, image processing, or performance metrics typically associated with AI/ML devices.
Yes
This device is a pedicle screw system intended for posterical fixation as an adjunct to fusion for various spinal conditions, indicating its use in treating medical conditions.
No
Explanation: The device is a pedicle screw system used for surgical fixation in the spine, not for diagnosing medical conditions. Its intended use lists conditions it is used to treat, not to diagnose.
No
The device description explicitly states that the system consists of rods, connectors, and screws for implantation, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Auxein Brand Vertaux 5.5 mm Pedicle Screw System is described as consisting of "rods, connectors and screws for implantation in the spine." This is a surgical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is for "posterical fixation in skeletally mature patients as an adjunct to fusion" for various spinal conditions. This is a therapeutic and structural purpose, not a diagnostic one based on analyzing samples.
The information provided clearly indicates this is a surgical implant used for spinal stabilization, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Auxein Brand Vertaux 5.5 mm Pedicle Screw System is intended for posterical fixation in sketally mature patients as an adjunct to fusion for the following indications:
Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
Spondylolisthesis;
Trauma (i.e., fracture or dislocation);
Spinal stenosis;
Curvatures (i.e., scoliosis, kyphosis and/or lordosis);
Tumor and pseudarthrosis
Product codes
NKB
Device Description
Auxein Brand Vertaux 5.5 mm Pedicle Screw System consists of rods, connectors and screws for implantation in the spine. The system is available in multiple rod diameters and screw sizes.
VERTAUX Mono-axial Pedicle Screw
The screw is threaded and the head is fixed for top loading for an easy rod introduction.
It may be used in instrumentation procedures to affix rods and screws to the spine. .
25 mm to 55 mm lengths & the diameter ranges from 4.5 mm to 7.0 mm. .
VERTAUX Poly-axial Pedicle Screw
It may be used in instrumentation procedures to affix rods and screws to the spine. 25 mm to 55 mm lengths & the diameter ranges from 4.5 mm to 6.5 mm.
VERTAUX-Pedicle Screws Cap
These cap is used to apply the pressure to hold the Rod inside the U-Part Head.
Buttress threads reduce profile and improves cross-threading resistance. .
Internal set screw allows for placement and visualization. .
VERTAUX -Pedicle Crosslink I & II
Vertaux Crosslink I
The Vertaux Crosslink I is used for connecting two vertaux rods providing a rigid and stable spine construct.
Vertaux Crosslink II
The intended use of vertaux cross link II is the same as used for cross link I with only change in design.
The Crosslink I is a pre assembled expandable part, while cross link II has assembly parts which are assembled during Surgery.
VERTAUX-Pedicle Rod
Auxein pedicle screw system has a titanium rod.
Easily contours to meet individual patient anatomy. .
These rods are available from 50mm, 60mm, 90mm, 100mm, 100mm, 110mm, 0 120mm, 130mm, 140mm, 150mm, 160mm, 180mm, 200mm, 220mm, 240mm, 250mm, 260mm, 280mm, 350mm, 400mm, 450mm, 500mm and having dia. of 5.5mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine, non-cervical
Indicated Patient Age Range
Skeletally mature 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)
Non-clinical testing performed against applicable product standards.
Material Standards:
ASTM F 136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
ASTM F 899-12: Standard Specification for Wrought Stainless Steels for surgical instruments
Performance Standards:
Static compression testing as per ASTM F 1717-18
Static Torsional Testing of as per ASTM F 1717-18
Fatigue Compression testing as per ASTM F 1717-18
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 091442
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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Auxein Medical Private Limited Rahul Luthra Director Plot No.168,169,170 Phase-4 Kundli Industrial Area, HSIIDC, Sector-57 Sonipath. Harvana 131028 India
Re: K201457
Trade/Device Name: Auxein Brand Vertaux 5.5 mm Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: March 3, 2021 Received: March 8, 2021
Dear Rahul Luthra:
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 Mav 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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
April 6, 2021
1
801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 53 1 -542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Anne D. Talley -S for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201457
Device Name
Auxein Brand Vertaux 5.5 mm Pedicle Screw System
Indications for Use (Describe)
The Auxein Brand Vertaux 5.5 mm Pedicle Screw System is intended for posterical fixation in sketally mature patients as an adjunct to fusion for the following indications:
· Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
·Spondylolisthesis;
·Trauma (i.e., fracture or dislocation);
·Spinal stenosis;
·Curvatures (i.e., scoliosis, kyphosis and/or lordosis);
·Tumor and pseudarthrosis
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows a logo with the word "Auxein" next to a circle with a stylized letter A inside. To the right of the logo, there is text that reads "K201457 Page 1 of 7". The logo and text are in a clear, legible font and appear to be part of a document or presentation.
Section 5.0 - 510K Summary
Premarket Notification 510(k) Summary as required by Section 807.92
General Company Information as required by 807.92 (a)
(A.1) The submitters name, address, telephone number, a contact person, and the date the summary was prepared
| Submitter's Name | Auxein Medical Private Limited. |
|---|---|
| Address: | Auxein Medical Pvt. Ltd. |
| Plot No. 168-169-170, Phase-4, | |
| Kundli Industrial Area, HSIIDC, | |
| Sector-57, Sonepat - 131028, Haryana, India | |
| Contact Person Name: | Mr. Rahul Luthra |
| Title: | Director |
| Phone Number: | +91-9811720999 |
| Dated: | 04.02.2021 |
Throughout the submission Auxein Brand Vertaux 5.5 mm Pedicle Screw System is covered under 510 (k) Submission.
A.2: The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
Proprietary Name:
Auxein Brand Vertaux 5.5 mm Pedicle Screw System
Common or Usual Name:
- Pedicle screw system .
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Image /page/4/Picture/0 description: The image shows the logo for Auxein, which is a blue circle with a white "A" inside of it, followed by the word "Auxein" in blue, stylized font. To the right of the logo is the text "K201457 Page 2 of 7". This text appears to be a document identifier and page number.
Classification Name:
- 0 Thoracolumbosacral pedicle screw system.
Product Code:
NKB
Device Class: II
Review Panel: Orthopedic
Regulation Number: 21 CFR 888.3070
Variants/Types:
Auxein Brand Vertaux 5.5 mm Pedicle Screw System consists of the following components:
| S.No. | Product Description |
|---|---|
| 1 | VERTAUX Mono-Axial Pedicle Screw |
| 2 | VERTAUX Poly-Axial Pedicle Screw |
| 3 | VERTAUX Pedicle Screw Cap |
| 4 | VERTAUX Crosslink-l |
| 5 | VERTAUX Crosslink-II |
| 6 | VERTAUX Rod |
A.3) Identification of the Predicate Device:
The identified primary predicate within this submission is as follows: K 091442, Medtronic Sofamor Danek, USA, CD HORIZON Spinal System
A.4). A description of the device that is the subject of the premarket notification submission, such as might be found in the labelling or promotional material for the device
Device Description:
Auxein Brand Vertaux 5.5 mm Pedicle Screw System consists of rods, connectors and screws for implantation in the spine. The system is available in multiple rod diameters and screw sizes.
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Image /page/5/Picture/0 description: The image shows the logo for Auxein. The logo consists of a stylized letter A inside of a circle, followed by the text "Auxein" in a sans-serif font. To the right of the logo is the text "K201457 Page 3 of 7".
VERTAUX Mono-axial Pedicle Screw
- 0 The screw is threaded and the head is fixed for top loading for an easy rod introduction.
- It may be used in instrumentation procedures to affix rods and screws to the spine. .
- 25 mm to 55 mm lengths & the diameter ranges from 4.5 mm to 7.0 mm. .
VERTAUX Poly-axial Pedicle Screw
It may be used in instrumentation procedures to affix rods and screws to the spine. 25 mm to 55 mm lengths & the diameter ranges from 4.5 mm to 6.5 mm.
VERTAUX-Pedicle Screws Cap
- 0 These cap is used to apply the pressure to hold the Rod inside the U-Part Head.
- Buttress threads reduce profile and improves cross-threading resistance. .
- Internal set screw allows for placement and visualization. .
VERTAUX -Pedicle Crosslink I & II
Vertaux Crosslink I
The Vertaux Crosslink I is used for connecting two vertaux rods providing a rigid and stable spine construct.
Vertaux Crosslink II
The intended use of vertaux cross link II is the same as used for cross link I with only change in design.
The Crosslink I is a pre assembled expandable part, while cross link II has assembly parts which are assembled during Surgery.
VERTAUX-Pedicle Rod
- 0 Auxein pedicle screw system has a titanium rod.
- Easily contours to meet individual patient anatomy. .
- These rods are available from 50mm, 60mm, 90mm, 100mm, 100mm, 110mm, 0 120mm, 130mm, 140mm, 150mm, 160mm, 180mm, 200mm, 220mm, 240mm, 250mm, 260mm, 280mm, 350mm, 400mm, 450mm, 500mm and having dia. of 5.5mm.
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Image /page/6/Picture/0 description: The image shows the logo for Auxein, which is a blue circle with a white letter A inside. To the right of the logo is the word "Auxein" in blue, and above that is the text "K201457 Page 4 of 7". The logo and text are all aligned horizontally.
These implants are sold in both non-sterile and sterile conditions. Note-Non sterile products have to be sterilized beforeuse.
A5). Indications for Use:
The Auxein Brand Vertaux 5.5 mm Pedicle Screw System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications:
- 0 Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- 0 Spondylolisthesis;
- Trauma (i.e., fracture or dislocation); 0
- 0 Spinal stenosis;
- . Curvatures (i.e., scoliosis, kyphosis and/orlordosis);
- . Tumor and pseudarthrosis
A.6). Summary of Technological Characteristics as compared to the predicate devices: Substantial equivalence including comparison with predicate devices
A comparison between the Auxein Brand Vertaux 5.5 mm Pedicle Screw System and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria.
Following is the summary of parameters in which the comparison has been verified:
| S.No. | Characteristics | Predicate Device Versus New Device (Auxein Brand) | Remarks |
|---|---|---|---|
| 1 | Indications for use | Similar intended use in New Device and Predicate device | Equivalent |
| 2 | Material | Same material used in New Device and Predicate device | Equivalent |
| 3 | Performance Standards | Same performance standards used in both New Device as well as predicate device | Equivalent |
| 4 | Sterilization | Same method of sterilization used in both | Equivalent |
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Image /page/7/Picture/0 description: The image shows the logo for Auxein, which is a blue circle with a white "A" inside of it, followed by the word "Auxein" in blue. To the right of the logo, the text "K201457" and "Page 5 of 7" are printed in black. The image appears to be a page from a document.
| New Device as well as | |||
|---|---|---|---|
| Predicate device | |||
| 5 | Dimensional Verification | Same dimensions found in | |
| both New Device as well as | |||
| Predicate device | Equivalent |
B.1). Discussion on the non-clinical testing performed
Following are the applicable product standards considered for non-clinical standards:
- A: Material Standards
- B: Performance Standards
A: Material Standards:
The material standards are the essential part to be complied with first, as it is the basis of manufacturing metallic surgical implants.
We have complied with the following material standards
-
ASTM F 136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
-
ASTM F 899-12: Standard Specification for Wrought Stainless Steels for surgical instruments
We have verified the purchased material compliance to these standards and copies of the Relevant test results are attached herewith.
B: Performance Standards:
The device performance of Auxein Brand Vertaux 5.5 mm Pedicle Screw System has been demonstrated against following applicable standards-
- 0 Static compression testing as per ASTM F 1717-18
- Static Torsional Testing of as per ASTM F 1717-18 0
- Fatigue Compression testing as per ASTM F 1717-18 0
B.2). Discussion on the clinical evaluation referenced and relied upon:
Auxein Brand of devices is of similar design and pattern as well as similar intended use. Under
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Image /page/8/Picture/0 description: The image shows the logo for Auxein, which includes a blue circle with a white "A" inside, followed by the word "Auxein" in blue. To the right of the logo, the text "K201457 Page 6 of 7" is displayed. The text appears to be a document identifier and page number.
such situation we have also considered the meddev guidance document MEDDEV 2.7 1 REV. 04: 2016 and as per that clinical evaluation/clinical equivalence has been documented in section 11.
CONCLUSION:
General, Safety and Performance conclusion:
| S.No. | Parameter of
Conclusion | Proposed Device | Predicate
Device |
|-------|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| 1 | Product Code | Auxein Brand Vertaux 5.5 mm Pedicle
Screw System. | Same |
| 2 | Regulation Number | 21CFR 888.3070 | Same |
| 3 | Regulatory Class | Class II | Same |
| 4 | Intended Use | Auxein Brand Vertaux 5.5 mm Pedicle
Screw System is intended for posterior,
non-cervical fixation in skeletally mature
patients as an adjunct to fusion for the
following indications:
• Degenerative Disc Disease (Defined
as back pain of discogenic origin
with degeneration of the disc
confirmed by history and
radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fracture or dislocation)
• Spinal Stenosis
• Curvatures (i.e. Scoliosis, kyphosis,
and/or lordosis)
• Tumor and pseudarthrosis | Same |
| 5 | Sterilization | Provided both in Non-Sterile and Sterile
Conditions. | Same |
| 6 | Mechanical Test
Performance | Auxein Brand Vertaux 5.5 mm Pedicle
Screw System tested -
• As per ASTM F 1717-18
Standard Test Methods for Spinal
Implant Constructs in a Vertebrectomy
Model | Same |
| 7 | Material Standards | ASTM F 136 (Implants) & ASTM
F899-12b (Instruments) / Same | |
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Image /page/9/Picture/0 description: The image shows the logo for Auxein, which is a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue. To the right of the logo, the text "K201457 Page 7 of 7" is displayed. The text is in black and appears to be a document identifier and page number.
From the data available we can justify that the Auxein Brand Vertaux 5.5 mm Pedicle Screw System has the same intended use and similar technological characteristics as the already marketed predicate device identified in A.3. of the 510(k) summary. Hence our device can be considered substantially equivalent to the predicate.