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ORTHROS Posterior Stabilization System - ORTHROS™ MIS Posterior Stabilization System
FDA 510(k)Class II (US FDA 510(k))
510(k) K180980
Identifiers
- 510(k) Number
- K180980 FDA 510(k)
- FDA Product Code
- NKB FDA 510(k)
- Models / Variants
- ORTHROS™ Posterior Stabilization System FDA 510(k)ORTHROS™ MIS Posterior Stabilization System 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)
ORTHROS Posterior Stabilization System - ORTHROS™ MIS Posterior Stabilization System by Camber Spine Technologies, Llc — Class II — FDA_510K — listed in FDA…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180980 | Class II | Active |
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Manufacturer
- Manufacturer
- Camber Spine Technologies, Llc
Sources (1)
- FDA 510(k) K180980 24 fields · synced Jun 18, 2026