Identity
- Trade Name
- MALLORY/HEAD CALCAR HIP SYSTEM FDA UDI
- Generic Name
- Coated femoral stem prosthesis, modular FDA UDI
- Model / Reference
- 108115 FDA UDI
Identifiers
- Catalog Number
- 108115 FDA UDI
- Primary DI / UDI-DI
- 00880304000636 FDA UDI
- FDA Product Code
- JDI FDA UDILPH FDA UDI
- GMDN Term
- Coated femoral stem prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3358 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: Coated femoral stem prosthesis, modular
Mallory/Head Calcar Hip System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated femoral stem prosthesis, modular.
- TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II
- STERIZO Total Hip System — CPM Medical Consultants, LLC · Class II
- PROFEMUR® — MicroPort Orthopedics Inc. · Class II
- Alteon — Exactech, Inc. · Class II
- ANTHOLOGY — Smith & Nephew, Inc. · Class III
- TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II
- Origin DAA Stem, Coxa Vara — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Cleared under the same submission
K031693 also covers:
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
K945115 also covers:
- BIOMET HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOMET HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOMET HIP SYSTEM — Biomet Orthopedics, Inc.
- Biomet® Hip System — Biomet Orthopedics, Inc.
- Biomet® Hip System — Biomet Orthopedics, Inc.
- Biomet® Hip System — Biomet Orthopedics, Inc.
- Biomet® Hip System — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc.
- MALLORY/HEAD CALCAR 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 f9fc616c-5a95-4b58-ab7a-c8a42ec9de7d 36 fields · synced Jun 8, 2026