Identity
- Trade Name
- M2a Magnum™ Hip System FDA UDIM2A MAGNUM HIP SYSTEM FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Model / Reference
- US157856 FDA UDI
Identifiers
- Catalog Number
- US157856 FDA UDI
- Primary DI / UDI-DI
- 00880304993525 FDA UDI00880304449466 FDA UDI
- FDA Product Code
- LZO FDA UDIKWY FDA UDILPH FDA UDIOQG 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
MR Unsafe 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
K042037 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.
- M2a Magnum™ Hip System — Biomet Orthopedics, Inc.
- SELEX® / 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 (2)
- FDA UDI d790971d-8cc2-4f1c-bb34-f3f172a6c322 36 fields · synced Jun 1, 2026
- FDA UDI 372f4e3b-8de2-4c26-a28b-eef34422abc0 36 fields · synced May 25, 2026