Identity
- Trade Name
- ALLOCLASSIC® ZWEYMÜLLER® SL FDA UDI
- Generic Name
- Press-fit hip femur prosthesis, modular FDA UDI
- Device Name
- ALLOCLASSIC SL Stem 3 12/14 FDA UDI
- Model / Reference
- 2843 FDA UDI
- Description
- ALLOCLASSIC SL Stem 3 12/14 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889024465565 FDA UDI
- 510(k) Number
- K030373 FDA UDI
- FDA Product Code
- LZO FDA UDIKWY FDA UDIJDI FDA UDIKWL FDA UDI
- GMDN Term
- Press-fit hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3390 FDA UDI888.3350 FDA UDI888.3360 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Press-fit hip femur prosthesis, modular
Alloclassic® Zweymüller® Sl by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Press-fit hip femur prosthesis, modular.
- Perfecta — MicroPort Orthopedics Inc. · Class III
- SUMMIT — DEPUY ORTHOPAEDICS, INC. · Class II
- Profemur — MicroPort Orthopedics Inc. · Class III
- Profemur — MicroPort Orthopedics Inc. · Class III
- UniSyn Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Profemur — MicroPort Orthopedics Inc. · Class II
- Perfecta — MicroPort Orthopedics Inc. · Class III
- Profemur — MicroPort Orthopedics Inc. · Class III
Cleared under the same submission
K030373 also covers:
- ALLOCLASSIC® ZWEYMÜLLER® SL — Zimmer, Inc.
- ALLOCLASSIC® ZWEYMÜLLER® SL — Zimmer, Inc.
- ALLOCLASSIC® ZWEYMÜLLER® SL — Zimmer, Inc.
- ALLOCLASSIC® ZWEYMÜLLER® SL — Zimmer, Inc.
- ALLOCLASSIC® ZWEYMÜLLER® SL — Zimmer, Inc.
- ALLOCLASSIC® ZWEYMÜLLER® SL — Zimmer, Inc.
- ALLOCLASSIC® ZWEYMÜLLER® SL — Zimmer, Inc.
- ALLOCLASSIC® ZWEYMÜLLER® SL — Zimmer, Inc.
- ALLOCLASSIC® ZWEYMÜLLER® SL — Zimmer, Inc.
- ALLOCLASSIC® ZWEYMÜLLER® SL — Zimmer, Inc.
- ALLOCLASSIC® ZWEYMÜLLER® SL — Zimmer, Inc.
- ALLOCLASSIC® ZWEYMÜLLER® SL — Zimmer, Inc.
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 |
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Manufacturer
- Manufacturer
- Zimmer, Inc.
Sources (1)
- FDA UDI 31be4a26-0c15-48d7-ab95-dfdc60017788 36 fields · synced May 30, 2026