2.0/2.3 Fixation Pl 2/4Hole L Right, t1.0
EUDAMEDFDA UDIClass IIb (EU MDR)
by Medartis AG
Identity
- Trade Name
- 2.0/2.3 Fixation Pl 2/4Hole L Right,t1.0 EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Bone plates (sterile, non-sterile) EUDAMED2.0/2.3 Fixation Pl 2/4Hole L Right,t1.0 FDA UDI
- Model / Reference
- A-4600.21S EUDAMEDFDA UDI
- Description
- 2.0/2.3 Fixation Pl 2/4Hole L Right,t1.0 FDA UDI
Identifiers
- Catalog Number
- A-4600.21S FDA UDI
- Primary DI / UDI-DI
- 07630037863359 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378020P6 EUDAMED
- 510(k) Number
- K232144 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
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
Yes
Manufacturing Date
Yes
Category: Orthopaedic fixation plate, non-bioabsorbable
2.0/2.3 Fixation Pl 2/4Hole L Right, t1.0 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 (2)
- EUDAMED 93c8f8af-593a-489a-a897-9bc33dee1755 61 fields · synced Jul 9, 2026
- FDA UDI e42b9762-fb42-435b-a0b4-c03a555de04f 35 fields · synced May 30, 2026