MUTARS® trial bar screw
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- MUTARS® EUDAMEDMUTARS® trial bar screw FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- - EUDAMED
- Model / Reference
- 77921018 EUDAMEDFDA UDIMUT12TBSINST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048844065546 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048844MUT12TBSINSTNG EUDAMED
- 510(k) Number
- K181778 FDA UDI
- FDA Product Code
- LZO FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3353 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: General internal orthopaedic fixation system implantation kit
MUTARS® trial bar screw by implantcast GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as General internal orthopaedic fixation system implantation kit.
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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 (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- implantcast GmbH
Sources (2)
- FDA UDI b8a1abe4-d32b-4723-bd5b-e09babdf87d2 34 fields · synced Oct 7, 2026
- EUDAMED 1807d954-43c2-4a1b-ba27-43779f0bb088 61 fields · synced Oct 7, 2026