Identity
- Trade Name
- MALLORY/HEAD PRIMARY HIP SYSTEM FDA UDI
- Generic Name
- Press-fit femoral stem prosthesis FDA UDI
- Model / Reference
- 11-104118 FDA UDI
Identifiers
- Catalog Number
- 11-104118 FDA UDI
- Primary DI / UDI-DI
- 00880304199149 FDA UDI
- FDA Product Code
- LPH FDA UDILZO FDA UDIMEH FDA UDI
- GMDN Term
- Press-fit femoral stem prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 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 femoral stem prosthesis
Mallory/Head Primary Hip System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Press-fit femoral stem prosthesis.
- Novation — Exactech, Inc. · Class II
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- Restoration — Howmedica Osteonics Corp. · Class II
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- Citation — Howmedica Osteonics Corp. · Class II
- OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
Cleared under the same submission
K030055 also covers:
- BALANCE HIP SYSTEM — Biomet Orthopedics, Inc.
- BALANCE HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC REVISION HIP SYSTEM — Biomet Orthopedics, Inc.
K921181 also covers:
- MALLORY HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD PRIMARY 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI a6f45878-de73-485b-a706-cf1daabff110 36 fields · synced May 30, 2026