Identity
- Trade Name
- Alloclassic® Zweymüller® SLO FDA UDI
- Generic Name
- Press-fit hip femur prosthesis, modular FDA UDI
- Device Name
- Alloclassic®, SL stem, offset, uncemented, 01, taper 12/14 FDA UDI
- Model / Reference
- 01.00121.001 FDA UDI
- Description
- Alloclassic®, SL stem, offset, uncemented, 01, taper 12/14 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889024278035 FDA UDI
- 510(k) Number
- K033664 FDA UDI
- FDA Product Code
- KWY FDA UDILZO FDA UDIKWL FDA UDIJDI FDA UDI
- GMDN Term
- Press-fit hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3390 FDA UDI888.3353 FDA UDI888.3360 FDA UDI888.3350 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
Yes
FDA UDI
Category: Press-fit hip femur prosthesis, modular
Alloclassic® Zweymüller® SLO 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
K033664 also covers:
- Alloclassic® Zweymüller® SLO — Zimmer, Inc.
- Alloclassic® Zweymüller® SLO — Zimmer, Inc.
- Alloclassic® Zweymüller® SLO — Zimmer, Inc.
- Alloclassic® Zweymüller® SLO — Zimmer, Inc.
- Alloclassic® Zweymüller® SLO — Zimmer, Inc.
- Alloclassic® Zweymüller® SLO — Zimmer, Inc.
- Alloclassic® Zweymüller® SLO — Zimmer, Inc.
- Alloclassic® Zweymüller® SLO — Zimmer, Inc.
- Alloclassic® Zweymüller® SLO — Zimmer, Inc.
- Alloclassic® Zweymüller® SLO — Zimmer, Inc.
- Alloclassic® Zweymüller® SLO — Zimmer, Inc.
- Alloclassic® Zweymüller® SLO — 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 d1bf2ac3-5fde-4648-a14e-ad06c3b3a65d 36 fields · synced May 30, 2026