Home / 510(k) Clearances / K151881

510(k) K151881

X-Fix Line Additions by Vilex IN Tennessee, Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2016
Date Received
July 9, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Vilex IN Tennessee, Inc.

  • K191289 — Bone Screw Line Addition (July 29, 2019)
  • K190543 — Cannulated Hemi Implant (May 31, 2019)
  • K163487 — Ultima HA Coated Half Pins and Wire (February 13, 2017)
  • K150211 — EzFuze Implant System (November 10, 2015)
  • K151456 — Small Bone Nail Implant (October 29, 2015)
  • K141937 — TRIDENT FUSION IMPLANT (September 10, 2014)

Other clearances for product code KTT

  • K253291 — Excelsior System (January 20, 2026)
  • K253202 — Hoffmann LRF System (December 19, 2025)
  • K253613 — Monkey Rings External Ring Fixation System (December 19, 2025)
  • K252555 — Medusa Orthopedics Boa External Fixation System (November 25, 2025)
  • K252625 — The Response Ortho Smart Fixator - Hexapod System (November 20, 2025)
  • K252106 — External Fixation Mini Rail System (September 30, 2025)
  • K251862 — External Fixation Bone Distractor (August 11, 2025)
  • K250472 — SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (August 8, 2025)
  • K251128 — Extremity Medical External Fixation System (May 7, 2025)
  • K243798 — Orthex External Fixation System (March 7, 2025)