Identifiers
- 510(k) Number
- K050666 FDA 510(k)
- FDA Product Code
- MQV FDA 510(k)
- Models / Variants
- Go-01g FDA 510(k)Go-05g FDA 510(k)Go-10g FDA 510(k)Go-15g FDA 510(k)Go-20g FDA 510(k)Go-30g FDA 510(k)Go-40g FDA 510(k)Go-60g FDA 510(k)Go-Xyz Series FDA 510(k)Go-Dz Series FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3045 FDA 510(k)
- Regulation Number
- 888.3045 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
GENEROS - Go-01g by Berkeley Advanced Biomaterials, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 10 models — regulatory data on deviCERTS
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 | K050666 | Class II | Active |
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Manufacturer
- Manufacturer
- Berkeley Advanced Biomaterials, Inc.
Sources (1)
- FDA 510(k) K050666 24 fields · synced Jun 18, 2026