Stryker Leibinger Resorbable Fixation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K993061 FDA 510(k)
- FDA Product Code
- MAI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Stryker Leibinger Resorbable Fixation System is a fastener, fixation, biodegradable, soft tissue device. It is classified as a device in the orthopedic medical specialty. The device is substantially equivalent to other devices on the market.
The system is supplied with various registration numbers, including 1221051 and 3010375065. It is regulated under the regulation number 888.3030 and has been authorized with an FDA 510K clearance. The device is used in orthopedic applications and is intended for fixation of soft tissue.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993061 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Instruments
Sources (1)
- FDA 510(k) K993061 24 fields · synced Sep 23, 2026