← Back to catalogue
ORTHROS™ Posterior Stabilization System +1 more model
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 +1 more model by Camber Spine Technologies, Llc — Class II — FDA_510K — listed in FDA 510(k) — 2 models
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Camber Spine Technologies, Llc
Sources (1)
- FDA 510(k) K180980 24 fields · synced Jun 18, 2026