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APEX HIP SYSTEM BIPOLAR HEAD - Yy=od In [mm](44-60)
FDA 510(k)Class II (US FDA 510(k))
510(k) K082468
Identifiers
- 510(k) Number
- K082468 FDA 510(k)
- FDA Product Code
- KWY FDA 510(k)
- Models / Variants
- H3-822xx FDA 510(k)H3-828yy FDA 510(k)Xx=od In [mm] (38-43) FDA 510(k)Yy=od In [mm](44-60) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3390 FDA 510(k)
- Regulation Number
- 888.3390 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
APEX HIP SYSTEM BIPOLAR HEAD - Yy=od In mm by OMNIlife science, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 4 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 | K082468 | Class II | Active |
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Manufacturer
- Manufacturer
- OMNIlife science, Inc.
- FDA Applicant
- Omni Life Science, Inc.
Sources (1)
- FDA 510(k) K082468 24 fields · synced Jun 18, 2026