Arthrex® AR-8665-28120S
Ref AR-8665-28120S
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 | Number0888867HedLesScrw000000AU 00888867259089 | Date11 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00888867259089 | Date16 Jan 2017 | 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- Withdrawn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
Made available in 27 countries, as listed in EUDAMED:
- Austria since 31 Oct 2025
- Belgium since 31 Oct 2025
- Bulgaria since 31 Oct 2025
- Croatia since 31 Oct 2025
- Cyprus since 31 Oct 2025
- Czechia since 31 Oct 2025
- Denmark since 31 Oct 2025
- Estonia since 31 Oct 2025
- Finland since 31 Oct 2025
- France since 31 Oct 2025
- Germany since 31 Oct 2025
- Greece since 31 Oct 2025
- Hungary since 31 Oct 2025
- Ireland since 31 Oct 2025
- Italy since 31 Oct 2025
- Latvia since 31 Oct 2025
- Lithuania since 31 Oct 2025
- Luxembourg since 31 Oct 2025
- Malta since 31 Oct 2025
- Netherlands since 31 Oct 2025
- Poland since 31 Oct 2025
- Portugal since 31 Oct 2025
- Romania since 31 Oct 2025
- Slovakia since 31 Oct 2025
- Slovenia since 31 Oct 2025
- Spain since 31 Oct 2025
- Sweden since 31 Oct 2025
Specification
- Trade Name
- Arthrex®
- Generic Name
- Orthopaedic bone screw (non-sliding)
- Device Name
- Headless Screw Family
- Model / Ref / Catalog
- AR-8665-28120S
- Primary DI / UDI-DI
- 00888867259089
- Basic UDI-DI
- 0888867HedLesScrw000000AU
- FDA Product Code
- HWC
- EMDN Code
- P09120603 Cannulated screws
- GMDN Term
- Orthopaedic bone screw (non-sliding)
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 888.3040
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Conditional
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class II |
Other devices from Arthrex, Inc.
Properties
Other properties (18)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No