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TAMINA 3.5mm Proximal Humerus System - TAMINA 3.5mm Proximal Humerus System
FDA 510(k)Class II (US FDA 510(k))
510(k) K231292
Identifiers
- 510(k) Number
- K231292 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
- Models / Variants
- TAMINA 3.5mm Proximal Humerus System FDA 510(k)POYA 3.5MM Lateral Proximal Tibia System FDA 510(k)LORRAINE 3.5mm Distal Humerus System 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)
TAMINA 3.5mm Proximal Humerus System - TAMINA 3.5mm Proximal Humerus System by Bonebridge AG — Class II — FDA_510K — listed in FDA 510(k) — 3 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 | K231292 | Class II | Active |
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Manufacturer
- Manufacturer
- Bonebridge AG
Sources (1)
- FDA 510(k) K231292 24 fields · synced Jun 19, 2026