Identity
- Trade Name
- MUTARS® screw FDA UDI
- Generic Name
- Implantable orthopaedic/craniofacial device connection screw FDA UDI
- Model / Reference
- 57921005 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048844115982 FDA UDI
- 510(k) Number
- K181778 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Implantable orthopaedic/craniofacial device connection screw 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: Implantable orthopaedic/craniofacial device connection screw
MUTARS® screw by implantcast GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable orthopaedic/craniofacial device connection screw.
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Cleared under the same submission
K181778 also covers:
- MUTARS® connecting part — implantcast GmbH
- MUTARS® extension piece — implantcast GmbH
- MUTARS® extension piece — implantcast GmbH
- MUTARS® extension piece — implantcast GmbH
- MUTARS® extension piece — implantcast GmbH
- MUTARS® femoral stem cementless — implantcast GmbH
- MUTARS® femoral stem cementless — implantcast GmbH
- MUTARS® femoral stem cementless — implantcast GmbH
- MUTARS® femoral stem cementless — implantcast GmbH
- MUTARS® femoral stem cementless — implantcast GmbH
- MUTARS® proximal femur — implantcast GmbH
- MUTARS® proximal femur — implantcast GmbH
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 3fe21679-3b72-4654-9c09-156c56310b17 34 fields · synced May 30, 2026