Identifiers
- 510(k) Number
- K130632 FDA 510(k)
- FDA Product Code
- NKB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3070 FDA 510(k)
- Regulation Number
- 888.3070 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sterispine PS Pedicle Screw is a pedicle screw device. It is substantially equivalent to a predicate device and has received FDA 510(k) clearance.
The device is supplied sterile and is intended for single-use. It is manufactured by Safe Orthopaedics and has been cleared under product code NKB with k-number K130632.
Frequently asked questions
What is the Sterispine PS Pedicle Screw used for?
The Sterispine PS Pedicle Screw is intended for spinal fixation as a pedicle screw device, providing stabilization in spinal procedures based on its substantial equivalence to a predicate device cleared under FDA 510(k).
Is the Sterispine PS Pedicle Screw sterile and single-use?
Yes, the device is supplied sterile and is intended for single-use only, as stated in its description, to ensure patient safety and prevent cross-contamination during surgical implantation.
What regulatory clearance does the Sterispine PS Pedicle Screw have?
The Sterispine PS Pedicle Screw has received FDA 510(k) clearance under k-number K130632 and product code NKB, confirming its substantial equivalence to a legally marketed predicate device.
Who manufactures the Sterispine PS Pedicle Screw and where is it made?
The device is manufactured by Safe Orthopaedics, located at Parc Des Bellevues, Allee R. Luxembourg - Le Californie, Eragny Sur Oise, FR 95610, France, as indicated in the manufacturer and address fields.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: safe-orthopaedics, PDF SteriSpine PS Pedcli e Screw System TM mSi ply Smart, Safe Orthopaedics: Efficacy of the Next-generation SteriSpine PS ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130632 | Class II | Active |
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Manufacturer
- Manufacturer
- Safe Orthopaedics
Sources (1)
- FDA 510(k) K130632 24 fields · synced Sep 24, 2026