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FDA 510(k)

Paragon 28 External Ring Fixation System

K-Number: K212895 · 2021-11-08

ApplicantParagon 28, Inc.
Decision Date2021-11-08
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Paragon 28 External Ring Fixation System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2021-11-08 under approval number K212895. 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 Paragon 28 External Ring Fixation System?

Paragon 28 External Ring Fixation System is a medical device that received FDA 510(k) clearance on 2021-11-08. It is manufactured by Paragon 28, Inc.. The 510(k) number is K212895.

When was Paragon 28 External Ring Fixation System approved by the FDA?

Paragon 28 External Ring Fixation System received FDA 510(k) clearance on 2021-11-08, under approval number K212895.

What company makes Paragon 28 External Ring Fixation System?

Paragon 28 External Ring Fixation System is manufactured by Paragon 28, Inc..

What is the FDA product code for Paragon 28 External Ring Fixation System?

The FDA product code for Paragon 28 External Ring Fixation System is KTT.

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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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