PMI Hip Femoral
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K923452 FDA 510(k)
- FDA Product Code
- LPH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3358 FDA 510(k)
- Regulation Number
- 888.3358 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PMI Hip Femoral is an orthopedic device classified as a Class 2 medical device with product code LPH. It is a patient-matched implant designed for hip femoral applications, as indicated by its device name and specifications.
The device received FDA 510(k) clearance under K923452 through the Traditional pathway after a 582-day review, with a decision date of February 16, 1994. It is manufactured by Biomet, Inc. and distributed as specified in the authorization and device data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K923452 FDA 510 (k) - PMI HIP FEMORAL | Biomet, Inc., PDF K923452 - Pmi Hip Femoral, Pmi (Patient Matched Implants) Hip Femoral Comp, PDF PMI Patient-Matched Implants - Zimmer Biomet
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K923452 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K923452 24 fields · synced Sep 26, 2026