Xtrafix Small External Fixation System
by Zimmer, Inc.
510(k) K131413
Xtrafix Small External Fixation System is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K131413 on 28 Jan 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 | NumberK131413 | Date28 Jan 2014 | StatusActive |
Official records
- FDA 510(k) database K131413
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- Withdrawn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