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2.8/3.5 TriLock Dist.Tib.Pl Antlat, 15H, L
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref A-4954.33S
by Medartis AG
Identity
- Trade Name
- 2.8/3.5 TriLock Dist.Tib.Pl Antlat,15H,L EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Bone plates (sterile, non-sterile) EUDAMED2.8/3.5 TriLock Dist.Tib.Pl Antlat,15H,L FDA UDI
- Model / Reference
- A-4954.33S EUDAMEDFDA UDI
- Description
- 2.8/3.5 TriLock Dist.Tib.Pl Antlat,15H,L FDA UDI
Identifiers
- Catalog Number
- A-4954.33S FDA UDI
- Primary DI / UDI-DI
- 07630037892472 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378020P6 EUDAMED
- 510(k) Number
- K193633 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
2.8/3.5 TriLock Dist.Tib.Pl Antlat, 15H, L by Medartis AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76300378020P6 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Medartis AG
- EUDAMED SRN
- CH-MF-000022291
- Authorised Representative
- Medartis GmbH DE-AR-000005810
Sources (2)
- EUDAMED e60ac40b-7bf2-4f74-a1ce-a942ae9c0cd9 61 fields · synced Jul 29, 2026
- FDA UDI d06a8e4f-749f-4c00-b92a-98eabfbe84b1 35 fields · synced May 30, 2026