Identity
- Trade Name
- Tandem FDA UDI
- Generic Name
- Metallic femoral head prosthesis FDA UDI
- Device Name
- TANDEM UNIPOLAR HEAD 46MM FDA UDI
- Model / Reference
- 126646 FDA UDI
- Description
- TANDEM UNIPOLAR HEAD 46MM FDA UDI
Identifiers
- Catalog Number
- 126646 FDA UDI
- Primary DI / UDI-DI
- 03596010079756 FDA UDI
- 510(k) Number
- K896580 FDA UDI
- FDA Product Code
- LZY FDA UDI
- GMDN Term
- Metallic femoral head prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3360 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: Metallic femoral head prosthesis
Tandem by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic femoral head prosthesis.
- Normmed CoCr Femoral Head 28 +12 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Orthinox — Howmedica Osteonics Corp. · Class II
- Orthinox — Howmedica Osteonics Corp. · Class II
- A110212031 — EUROS SAS · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- BIOMET HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Femoral Head — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Cleared under the same submission
K896580 also covers:
- Tandem — Smith & Nephew, Inc.
- Tandem — Smith & Nephew, Inc.
- Tandem — Smith & Nephew, Inc.
- Tandem — Smith & Nephew, Inc.
- Tandem — Smith & Nephew, Inc.
- Tandem — Smith & Nephew, Inc.
- Tandem — Smith & Nephew, Inc.
- Tandem — Smith & Nephew, Inc.
- Tandem — Smith & Nephew, Inc.
- Tandem — Smith & Nephew, Inc.
- Tandem — Smith & Nephew, Inc.
- Tandem — Smith & Nephew, 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI bb4aaa20-5578-4d05-8e61-2901bcb2b2a0 36 fields · synced Jun 8, 2026