Identity
- Trade Name
- BI-METRIC HIP SYSTEM FDA UDI
- Generic Name
- Uncoated femoral stem prosthesis, one-piece FDA UDI
- Model / Reference
- CP152445 FDA UDI
Identifiers
- Catalog Number
- CP152445 FDA UDI
- Primary DI / UDI-DI
- 00880304042049 FDA UDI
- FDA Product Code
- MEH FDA UDILPH FDA UDILZO FDA UDI
- GMDN Term
- Uncoated femoral stem prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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: Uncoated femoral stem prosthesis, one-piece
Bi-Metric Hip System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated femoral stem prosthesis, one-piece.
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class III
- Alteon — Exactech, Inc. · Class II
- OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
- Novation — Exactech, Inc. · Class II
- Evolve Masters — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Acumatch C Series — Exactech, Inc. · 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 REVISION HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC REVISION HIP SYSTEM — Biomet Orthopedics, Inc.
K921224 also covers:
- BALANCE HIP SYSTEM — Biomet Orthopedics, Inc.
- BALANCE HIP SYSTEM — Biomet Orthopedics, Inc.
- BALANCE HIP SYSTEM — Biomet Orthopedics, Inc.
- BALANCE HIP SYSTEM — Biomet Orthopedics, Inc.
- BALANCE HIP SYSTEM — Biomet Orthopedics, Inc.
- BALANCE HIP SYSTEM — Biomet Orthopedics, Inc.
- 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.
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 fe45237f-1b80-4f23-afd2-bed35af4cae1 36 fields · synced May 30, 2026