2.5/2.8 Biconcave Washer, 1/Pkg
EUDAMEDFDA UDIClass IIb (EU MDR)
by Medartis AG
Identity
- Trade Name
- 2.5/2.8 Biconcave Washer, 1/Pkg EUDAMED2.5/2.8 Biconcave Washer, 5/Pkg EUDAMEDAPTUS FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Device Name
- Bone plates (sterile, non-sterile) EUDAMED2.5/2.8 Biconcave Washer, 5/Pkg FDA UDI2.5/2.8 Biconcave Washer, 1/Pkg FDA UDI
- Model / Reference
- A-4750.70/1 EUDAMEDFDA UDIA-4750.70 EUDAMEDFDA UDI
- Description
- 2.5/2.8 Biconcave Washer, 5/Pkg FDA UDI2.5/2.8 Biconcave Washer, 1/Pkg FDA UDI
Identifiers
- Catalog Number
- A-4750.70 FDA UDIA-4750.70/1 FDA UDI
- Primary DI / UDI-DI
- 07630037863663 EUDAMEDFDA UDI07630037863656 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378020P6 EUDAMED
- Unit of Use DI
- 07630037800767 EUDAMED
- 510(k) Number
- K112560 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
- GMDN Term
- Implantable bone washer 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
No
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
2.5/2.8 Biconcave Washer, 1/Pkg by Medartis AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Traufix osteosynthesis, osteotomy, and arthrodesis devices — Fixier S.A. DE C.V. · Class II
- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- AXSOS — Stryker Corp. · Class II
- Xpert Wrist — NEWCLIP TECHNICS · Class II
- ACUMED — ACUMED LLC · Class II
- Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medartis AG
- EUDAMED SRN
- CH-MF-000022291
- Authorised Representative
- Medartis GmbH DE-AR-000005810
Sources (4)
- EUDAMED 60d56330-4ade-4301-92a1-2631696f6efa 61 fields · synced Aug 1, 2026
- FDA UDI 13c17f54-3ac3-4730-a5f7-3169b9c51daa 35 fields · synced May 29, 2026
- FDA UDI acc03a04-cf3c-426c-b813-6a018b6c8efe 35 fields · synced May 30, 2026
- EUDAMED 8ba39ce7-bbf5-47c8-8623-f1387f7c4998 61 fields · synced Jul 10, 2026