3.5mm Full Radius 908510
3.5mm Full Radius 908510 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K920800 on 30 Jun 1992 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00880304410404), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00880304410404 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK920800 | Date30 Jun 1992 | StatusActive |
Official records
- AccessGUDID record 00880304410404
- FDA 510(k) database K920800
Across registries
- FDA 510(k) K920800 decided 30 Jun 1992 Active
- FDA GUDID UDI-DI 00880304410404 listed 22 Sep 2016 Listed
Recalls
-
- Terminated Z-1818-2016
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
Timeline
- Cleared FDA 510(k) K920800
- Recall initiated FDA recalls Z-1818-2016
- Listed FDA GUDID 00880304410404
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- 3.5mm Full Radius
- Generic name
- Arthroscopic shaver system blade, single-use
- Model / Ref / Catalog
- 908510
- Primary DI / UDI-DI
- 00880304410404
- 510(k) Number
- FDA product code
- HRX
- GMDN term
- Arthroscopic shaver system blade, single-use
- Device class
- Class II
- Regulation number
- 888.1100
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Arthroscopic shaver system blade, single-use.