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FDA 510(k)

Arrowhead Mini-Rail Fixator

K-Number: K162032 · 2017-02-21

ApplicantArrowhead De, LLC
Decision Date2017-02-21
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arrowhead Mini-Rail Fixator is a medical device manufactured by Arrowhead De, LLC. It received FDA 510(k) clearance on 2017-02-21 under approval number K162032. 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 Arrowhead Mini-Rail Fixator?

Arrowhead Mini-Rail Fixator is a medical device that received FDA 510(k) clearance on 2017-02-21. It is manufactured by Arrowhead De, LLC. The 510(k) number is K162032.

When was Arrowhead Mini-Rail Fixator approved by the FDA?

Arrowhead Mini-Rail Fixator received FDA 510(k) clearance on 2017-02-21, under approval number K162032.

What company makes Arrowhead Mini-Rail Fixator?

Arrowhead Mini-Rail Fixator is manufactured by Arrowhead De, LLC.

What is the FDA product code for Arrowhead Mini-Rail Fixator?

The FDA product code for Arrowhead Mini-Rail Fixator is KTT.

Other Devices by Arrowhead De, LLC

K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) K200123Accessories for the SixFix® Hexapod Fixator

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

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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