Xpert Ankle
510(k) K261511
Xpert Ankle is a Class II device made by Newclip Technics SAS, cleared under FDA 510(k) K261511 on 28 Jul 2026, 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 | NumberK261511 | Date28 Jul 2026 | StatusActive |
Official records
- FDA 510(k) database K261511
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRS
- FDA applicant
- Newclip Technics
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent