Identity
- Trade Name
- M2a Magnum™ Hip System FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Model / Reference
- US257858 FDA UDI
Identifiers
- Catalog Number
- US257858 FDA UDI
- Primary DI / UDI-DI
- 00880304993655 FDA UDI
- FDA Product Code
- LZO FDA UDIKWY FDA UDIOQG FDA UDILPH FDA UDIKWA FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3390 FDA UDI888.3358 FDA UDI888.3330 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: Acetabular shell
M2a Magnum™ Hip System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K062995 also covers:
- M2a Magnum™ Hip System — Biomet Orthopedics, Inc.
- M2a Magnum™ Hip System — Biomet Orthopedics, Inc.
- M2a Magnum™ Hip System — Biomet Orthopedics, Inc.
- M2a Magnum™ Hip System — Biomet Orthopedics, Inc.
- M2a Magnum™ Hip System — Biomet Orthopedics, Inc.
- M2a Magnum™ Hip System — Biomet Orthopedics, Inc.
- M2a Magnum™ Hip System — Biomet Orthopedics, Inc.
- M2a Magnum™ Hip System — Biomet Orthopedics, Inc.
- M2a Magnum™ Hip System — Biomet Orthopedics, Inc.
- M2a Magnum™ Hip System — Biomet Orthopedics, Inc.
K101336 also covers:
- ACTIVE ARTICULATION™ HIP SYSTEM INLAY HEAD PRESS — Biomet Orthopedics, Inc.
- Active Articulation Hip System — Biomet Orthopedics, Inc.
- Active Articulation Hip System — Biomet Orthopedics, Inc.
- Active Articulation Hip System — Biomet Orthopedics, Inc.
- Active Articulation Hip System — Biomet Orthopedics, Inc.
- Active Articulation Hip System — Biomet Orthopedics, Inc.
- Active Articulation Hip System — Biomet Orthopedics, Inc.
- Active Articulation Hip System — Biomet Orthopedics, Inc.
- Active Articulation Hip System — Biomet Orthopedics, Inc.
- Active Articulation Hip System — Biomet Orthopedics, Inc.
- Active Articulation Hip System — Biomet Orthopedics, Inc.
- Active Articulation™ Hip System — Biomet Orthopedics, 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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 0e1eaa0c-85f8-43fd-a90b-640a5121fec3 36 fields · synced Jun 8, 2026