FDA 510(k)

X-Fix Line Additions

K-Number: K151881 · 2016-03-24

Decision Date2016-03-24

Product CodeKTT

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

X-Fix Line Additions is a medical device manufactured by Vilex IN Tennessee, Inc.. It received FDA 510(k) clearance on 2016-03-24 under approval number K151881. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-Fix Line Additions?

X-Fix Line Additions is a medical device that received FDA 510(k) clearance on 2016-03-24. It is manufactured by Vilex IN Tennessee, Inc.. The 510(k) number is K151881.

When was X-Fix Line Additions approved by the FDA?

X-Fix Line Additions received FDA 510(k) clearance on 2016-03-24, under approval number K151881.

What company makes X-Fix Line Additions?

X-Fix Line Additions is manufactured by Vilex IN Tennessee, Inc..

What is the FDA product code for X-Fix Line Additions?

The FDA product code for X-Fix Line Additions is KTT.

Other Devices by Vilex IN Tennessee, Inc.

K163487Ultima HA Coated Half Pins and Wire K191289Bone Screw Line Addition K190543Cannulated Hemi Implant

Related Devices (Code: KTT)

K160972Gexfix External FixationGexfix International Corp. K161753Hoffman LRF SystemStryker GmbH K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC K160830Integra External Fixation SystemAscension Orthopedics K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH K151580D.N.E. External Fixation SystemDne, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.