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Apex Knee System (Kc-230xy +2 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K080842
Identifiers
- 510(k) Number
- K080842 FDA 510(k)
- FDA Product Code
- MBH FDA 510(k)
- Models / Variants
- Kc-230xy FDA 510(k)Kc-240xy [ No Holes FDA 510(k)2 Holes] FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3565 FDA 510(k)
- Regulation Number
- 888.3565 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Apex Knee System (Kc-230xy +2 more) by OMNIlife science, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 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 | K080842 | Class II | Active |
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Manufacturer
- Manufacturer
- OMNIlife science, Inc.
- FDA Applicant
- Omni Life Science, Inc.
Sources (1)
- FDA 510(k) K080842 24 fields · synced Jun 18, 2026