Buchalter Fauser Femoral Components
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K952686 FDA 510(k)
- FDA Product Code
- LZO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3353 FDA 510(k)
- Regulation Number
- 888.3353 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Buchalter Fauser Femoral Components are orthopedic surgical implants designed for use in hip replacement procedures. These components serve as the femoral portion of a prosthetic hip system.
This device is manufactured by Biomet, Inc. and has received FDA 510(k) clearance under K952686. It is categorized under product code LZO for orthopedic applications.
Frequently asked questions
What is the intended use of the Buchalter Fauser Femoral Components?
These components are orthopedic surgical implants designed to serve as the femoral portion of a prosthetic hip system during hip replacement procedures.
Who is the manufacturer of this femoral component?
The Buchalter Fauser Femoral Components are manufactured by Biomet, Inc., based in Warsaw, Indiana.
What is the regulatory status of this device?
The Buchalter Fauser Femoral Components have received FDA 510(k) clearance under K952686, having been determined to be substantially equivalent to existing devices.
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: BUCHALTER FAUSER FEMORAL COMPONENTS (K952686) — FDA 510 (k) | Innolitics, K952686 - BUCHALTER FAUSER FEMORAL COMPONENTS | FDA 510 (k), Buchalter Fauser Femoral Components 510(k) K952686 - FDA.report, PDF K952686 - Buchalter Fauser Femoral Components, Biomed Prosthetic Devices for Total Hip Replacement
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K952686 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K952686 24 fields · synced Sep 25, 2026