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FDA 510(k)

QuikFix External Fixator: Knee-Spanning Pack

K-Number: K260112 · 2026-03-23

ApplicantStabiliz Orthopaedics, Inc.
Decision Date2026-03-23
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

QuikFix External Fixator: Knee-Spanning Pack is the device name listed in this FDA 510(k) record. The listed applicant is Stabiliz Orthopaedics, Inc.. It received FDA 510(k) clearance on 2026-03-23 under 510(k) number K260112. 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 QuikFix External Fixator: Knee-Spanning Pack?

QuikFix External Fixator: Knee-Spanning Pack is a medical device that received FDA 510(k) clearance on 2026-03-23. The listed applicant is Stabiliz Orthopaedics, Inc.. The 510(k) number is K260112.

When did QuikFix External Fixator: Knee-Spanning Pack receive FDA 510(k) clearance?

QuikFix External Fixator: Knee-Spanning Pack received FDA 510(k) clearance on 2026-03-23, under 510(k) number K260112.

Who is the listed applicant for QuikFix External Fixator: Knee-Spanning Pack?

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

What is the FDA product code for QuikFix External Fixator: Knee-Spanning Pack?

The FDA product code for QuikFix External Fixator: Knee-Spanning Pack is KTT.

Other records listing Stabiliz Orthopaedics, Inc. 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.

K230053SimpliFix Hip System

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, LLCK253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbHK252555Medusa Orthopedics Boa External Fixation SystemMedusa Orthopedics, LLC

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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