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FDA 510(k)

External Fixation Bone Distractor

K-Number: K251862 · 2025-08-11

ApplicantParagon 28, Inc.
Decision Date2025-08-11
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

External Fixation Bone Distractor is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2025-08-11 under 510(k) number K251862. 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 External Fixation Bone Distractor?

External Fixation Bone Distractor is a medical device that received FDA 510(k) clearance on 2025-08-11. The listed applicant is Paragon 28, Inc.. The 510(k) number is K251862.

When did External Fixation Bone Distractor receive FDA 510(k) clearance?

External Fixation Bone Distractor received FDA 510(k) clearance on 2025-08-11, under 510(k) number K251862.

Who is the listed applicant for External Fixation Bone Distractor?

The FDA 510(k) record lists Paragon 28, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for External Fixation Bone Distractor?

The FDA product code for External Fixation Bone Distractor is KTT.

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Other records listing Paragon 28, Inc. as applicant

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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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