Identifiers
- 510(k) Number
- K133893 FDA 510(k)
- FDA Product Code
- MAX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3080 FDA 510(k)
- Regulation Number
- 888.3080 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sterispine Lc Cage is an intervertebral body fusion device designed for lumbar spinal fusion. It is constructed from PEEK with Tantalum markers for radiographic purposes and features a central cavity for autogenous bone graft to promote fusion. The device is available in straight or curved configurations.
The Sterispine Lc Cage is supplied as a sterile implant and is intended for single-use. It is available in various sizes and configurations, including straight and curved options. The device has received FDA 510K authorization and is classified under the product code MAX.
Frequently asked questions
What is the Sterispine LC Cage made of?
The Sterispine LC Cage is constructed from PEEK with Tantalum markers for radiographic purposes.
Is the Sterispine LC Cage supplied sterile?
Yes, the Sterispine LC Cage is supplied as a sterile implant and is intended for single-use.
What configurations is the Sterispine LC Cage available in?
The Sterispine LC Cage is available in straight or curved configurations and various sizes.
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, Safe Orthopaedics - SPINEMarketGroup, STERISPINE LC CAGE (K151756) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133893 | Class II | Active |
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Manufacturer
- Manufacturer
- Safe Orthopaedics
Sources (1)
- FDA 510(k) K133893 24 fields · synced Sep 26, 2026