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FDA 510(k)

Accessories for the SixFix® Hexapod Fixator

K-Number: K200123 · 2020-09-22

ApplicantArrowhead De, LLC
Decision Date2020-09-22
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Accessories for the SixFix® Hexapod Fixator is the device name listed in this FDA 510(k) record. The listed applicant is Arrowhead De, LLC. It received FDA 510(k) clearance on 2020-09-22 under 510(k) 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. The listed applicant is Arrowhead De, LLC. The 510(k) number is K200123.

When did Accessories for the SixFix® Hexapod Fixator receive FDA 510(k) clearance?

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

Who is the listed applicant for Accessories for the SixFix® Hexapod Fixator?

The FDA 510(k) record lists Arrowhead De, LLC as the applicant. This does not by itself establish the device manufacturer.

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 records listing Arrowhead De, LLC as applicant

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.

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

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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