FDA 510(k)

Accessories for the SixFix® Hexapod Fixator

K-Number: K200123 · 2020-09-22

Decision Date2020-09-22

Product CodeKTT

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Accessories for the SixFix® Hexapod Fixator is a medical device manufactured by Arrowhead De, LLC. It received FDA 510(k) clearance on 2020-09-22 under approval number K200123. 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 Accessories for the SixFix® Hexapod Fixator?

Accessories for the SixFix® Hexapod Fixator is a medical device that received FDA 510(k) clearance on 2020-09-22. It is manufactured by Arrowhead De, LLC. The 510(k) number is K200123.

When was Accessories for the SixFix® Hexapod Fixator approved by the FDA?

Accessories for the SixFix® Hexapod Fixator received FDA 510(k) clearance on 2020-09-22, under approval number K200123.

What company makes Accessories for the SixFix® Hexapod Fixator?

Accessories for the SixFix® Hexapod Fixator is manufactured by Arrowhead De, LLC.

What is the FDA product code for Accessories for the SixFix® Hexapod Fixator?

The FDA product code for Accessories for the SixFix® Hexapod Fixator is KTT.

Other Devices by Arrowhead De, LLC

K162032Arrowhead Mini-Rail Fixator K190069SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

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 K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.

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.