Identity
- Trade Name
- MUTARS® femoral stem cemented FDA UDI
- Generic Name
- Uncoated femoral stem prosthesis, modular FDA UDI
- Model / Reference
- 57600013 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048844049645 FDA UDI
- 510(k) Number
- K200045 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Uncoated femoral stem prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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: Uncoated femoral stem prosthesis, modular
MUTARS® femoral stem cemented by implantcast GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated femoral stem prosthesis, modular.
- Performa — IMPLANTS INTERNATIONAL LTD · Class II
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- GUARDIAN® — MicroPort Orthopedics Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- Performa — IMPLANTS INTERNATIONAL LTD · Class II
- Performa — IMPLANTS INTERNATIONAL LTD · Class II
Cleared under the same submission
K200045 also covers:
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
- implantcast GmbH
Sources (1)
- FDA UDI 4f73da73-37ee-467c-9968-620df8774231 34 fields · synced Jun 1, 2026