Identity
- Trade Name
- Avenir® Müller FDA UDI
- Generic Name
- Coated hip femur prosthesis, modular FDA UDI
- Device Name
- Avenir Müller stem 2 Standard FDA UDI
- Model / Reference
- 01.06010.002 FDA UDI
- Description
- Avenir Müller stem 2 Standard FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889024288058 FDA UDI
- 510(k) Number
- K123392 FDA UDI
- FDA Product Code
- JDI FDA UDIKWY FDA UDIMEH FDA UDIKWZ FDA UDILZO FDA UDILWJ FDA UDI
- GMDN Term
- Coated hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3390 FDA UDI888.3353 FDA UDI888.3310 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
Yes
FDA UDI
Category: Coated hip femur prosthesis, modular
Avenir® Müller by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated hip femur prosthesis, modular.
- LCU Hip Stem — WALDEMAR LINK GmbH & Co. KG · Class II
- ABG — Howmedica Osteonics Corp. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- CATALYSTEM — Smith & Nephew, Inc. · Class II
- Everglade Stem, Standard Offset — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Excia® L — AESCULAP, INC. · Class II
- SYNERGY — Smith & Nephew, Inc. · Class II
- SYNERGY — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K123392 also covers:
- Avenir — Zimmer, Inc.
- Avenir® Müller — Zimmer, Inc.
- Avenir® Müller — Zimmer, Inc.
- Avenir® Müller — Zimmer, Inc.
- Avenir® Müller — Zimmer, Inc.
- Avenir® Müller — Zimmer, Inc.
- Avenir® Müller — Zimmer, Inc.
- Avenir® Müller — Zimmer, Inc.
- Avenir® Müller — Zimmer, Inc.
- Avenir® Müller — Zimmer, Inc.
- Avenir® Müller — Zimmer, Inc.
- Avenir® Müller — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zimmer, Inc.
Sources (1)
- FDA UDI 886f58e9-52a1-45d8-9371-e208a838b499 36 fields · synced May 30, 2026