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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 the device name listed in this FDA 510(k) record. The listed applicant is Gexfix International Corp.. It received FDA 510(k) clearance on 2016-12-28 under 510(k) 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. The listed applicant is Gexfix International Corp.. The 510(k) number is K160972.

When did Gexfix External Fixation receive FDA 510(k) clearance?

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

Who is the listed applicant for Gexfix External Fixation?

The FDA 510(k) record lists Gexfix International Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gexfix External Fixation?

The FDA product code for Gexfix External Fixation is KTT.

Related Devices (Code: KTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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