Arthrex®
by Arthrex Inc
Ref AR-1360FT-KFT
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0888867BIntScrwImpSys00ZN 00888867520745 | Date1 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00888867520745 | Date21 Jan 2026 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
EU market availability
Not listed: EUDAMED names no country where this device is made available.
Specification
- Generic Name
- Bioabsorbable orthopaedic bone screw
- Device Name
- Bioabsorbable Interference Screw Implant Systems
- Model / Ref / Catalog
- AR-1360FT-KFT
- Primary DI / UDI-DI
- 00888867520745
- Basic UDI-DI
- 0888867BIntScrwImpSys00ZN
- FDA Product Code
- MBI
- EMDN Code
- P09120606 Osteosynthesis devices, biodegradable screws and bars
- GMDN Term
- Bioabsorbable orthopaedic bone screw
- Device Class
- Class III EUDAMEDClass II GUDID
- Regulation Number
- 888.3040
- Medical Purpose
- Procedure Packs are combinations of medical devices packaged together and placed on the market with the purpose of treatment for orthopedic pathologies
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Safe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class III | Class II |
Manufacturer details
- EUDAMED SRN
- US-PR-000048028
Other devices from Arthrex, Inc.
Properties
Other properties (7)
- Contains Latex: No
- Over-the-Counter: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No