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FDA 510(k)

Gexfix External Fixation

K-Number: K160972 · 2016-12-28

ApplicantGexfix International Corp.
Decision Date2016-12-28
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Gexfix External Fixation is a medical device manufactured by Gexfix International Corp.. It received FDA 510(k) clearance on 2016-12-28 under approval number K160972. 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 Gexfix External Fixation?

Gexfix External Fixation is a medical device that received FDA 510(k) clearance on 2016-12-28. It is manufactured by Gexfix International Corp.. The 510(k) number is K160972.

When was Gexfix External Fixation approved by the FDA?

Gexfix External Fixation received FDA 510(k) clearance on 2016-12-28, under approval number K160972.

What company makes Gexfix External Fixation?

Gexfix External Fixation is manufactured by Gexfix International Corp..

What is the FDA product code for Gexfix External Fixation?

The FDA product code for Gexfix External Fixation is KTT.

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Related Devices (Code: KTT)

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 K151881X-Fix Line AdditionsVilex IN Tennessee, Inc. K151580D.N.E. External Fixation SystemDne, LLC

Official Source

View on FDA Database →

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

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