3.5 TriLock Prox. Humeral Plate, 7H, R
EUDAMEDFDA UDIClass IIb (EU MDR)
by Medartis AG
Identity
- Trade Name
- 3.5 TriLock Prox. Humeral Plate, 7H, R EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Bone plates (sterile, non-sterile) EUDAMED3.5 TriLock Prox. Humeral Plate, 7H, R FDA UDI
- Model / Reference
- A-4951.06S EUDAMEDA-4951.06 EUDAMEDFDA UDI
- Description
- 3.5 TriLock Prox. Humeral Plate, 7H, R FDA UDI
Identifiers
- Catalog Number
- A-4951.06 FDA UDI
- Primary DI / UDI-DI
- 07630037892076 EUDAMED07630037896142 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378020P6 EUDAMED
- 510(k) Number
- K120108 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile 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
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
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
Yes
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
Yes
Category: Orthopaedic fixation plate, non-bioabsorbable
3.5 TriLock Prox. Humeral Plate, 7H, R by Medartis AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 (3)
- EUDAMED 3b5c6588-8482-4040-8ca9-7f54823e30ab 61 fields · synced Oct 6, 2026
- FDA UDI f3bb3b59-d143-4742-8f20-6b9b0a769270 35 fields · synced May 29, 2026
- EUDAMED 3da441f4-ae68-49c5-ae4b-d1693c15fe89 61 fields · synced Jul 11, 2026