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FDA 510(k)

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

K-Number: K250472 · 2025-08-08

ApplicantAmdt Holdings, Inc.
Decision Date2025-08-08
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is the device name listed in this FDA 510(k) record. The listed applicant is Amdt Holdings, Inc.. It received FDA 510(k) clearance on 2025-08-08 under 510(k) number K250472. 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 SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Amdt Holdings, Inc.. The 510(k) number is K250472.

When did SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) receive FDA 510(k) clearance?

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) received FDA 510(k) clearance on 2025-08-08, under 510(k) number K250472.

Who is the listed applicant for SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?

The FDA 510(k) record lists Amdt Holdings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?

The FDA product code for SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) 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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