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ICUFF REPAIR PLATE, RIGHT - Anchor Bolt, 10mm Through 50mm
FDA 510(k)Class II (US FDA 510(k))
510(k) K102539
Identifiers
- 510(k) Number
- K102539 FDA 510(k)
- FDA Product Code
- MBI FDA 510(k)
- Models / Variants
- Icuff Repair Plate, Right FDA 510(k)Cuff Repair Plate. Left FDA 510(k)Anchor Bolt, 10mm Through 50mm FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ICUFF REPAIR PLATE, RIGHT - Anchor Bolt, 10mm Through 50mm by Shoulder Options, Inc. — 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 | K102539 | Class II | Active |
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Manufacturer
- Manufacturer
- Shoulder Options, Inc.
Sources (1)
- FDA 510(k) K102539 24 fields · synced Jun 18, 2026