Xtrafix External Fixation System, Xtrafix Small External Fixation System
by Zimmer, Inc.
510(k) K141697
Xtrafix External Fixation System, Xtrafix Small External Fixation System is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K141697 on 18 Sep 2014, 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 | NumberK141697 | Date18 Sep 2014 | StatusActive |
Official records
- FDA 510(k) database K141697
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KTT
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent