Identity
- Trade Name
- Biolox FDA UDI
- Generic Name
- Femoral head/stem prosthesis adaptor FDA UDI
- Device Name
- Universal Taper Femoral Head FDA UDI
- Model / Reference
- 6519-1-032 FDA UDI
- Description
- Universal Taper Femoral Head FDA UDI
Identifiers
- Catalog Number
- 6519-1-032 FDA UDI
- Primary DI / UDI-DI
- 04546540608420 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Femoral head/stem prosthesis adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 32.0 Millimeter FDA UDI
Category: Femoral head/stem prosthesis adaptor
Biolox by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K070885 also covers:
K173499 also covers:
- Adapter Sleeve — Howmedica Osteonics Corp.
- Alumina — Howmedica Osteonics Corp.
- Alumina — Howmedica Osteonics Corp.
- Alumina — Howmedica Osteonics Corp.
- Alumina — Howmedica Osteonics Corp.
- Alumina — Howmedica Osteonics Corp.
- Alumina — Howmedica Osteonics Corp.
- Biolox — Howmedica Osteonics Corp.
- Biolox — Howmedica Osteonics Corp.
- Biolox — Howmedica Osteonics Corp.
- EXETER — Howmedica Osteonics Corp.
- EXETER — Howmedica Osteonics Corp.
K243784 also covers:
- Adapter Sleeve — Howmedica Osteonics Corp.
- Adapter Sleeve — Howmedica Osteonics Corp.
- Adapter Sleeve — Howmedica Osteonics Corp.
- Alumina — Howmedica Osteonics Corp.
- Alumina — Howmedica Osteonics Corp.
- Alumina — Howmedica Osteonics Corp.
- Alumina — Howmedica Osteonics Corp.
- Alumina — Howmedica Osteonics Corp.
- Alumina — Howmedica Osteonics Corp.
- Alumina — Howmedica Osteonics Corp.
- Alumina — Howmedica Osteonics Corp.
- Biolox — Howmedica Osteonics Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Howmedica Osteonics Corp.
Sources (1)
- FDA UDI e32be141-ac18-4d8a-a17a-ed1cff056ccc 36 fields · synced May 31, 2026