Arthrex Univers II Ca Heads
510(k) K130675
Arthrex Univers II Ca Heads is a Class II device made by Arthrex, Inc., cleared under FDA 510(k) K130675 on 30 Oct 2013, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130675 | Date30 Oct 2013 | StatusActive |
Official records
- FDA 510(k) database K130675
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HSD
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3690
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent