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FDA 510(k)

ONX Large External Fixation System

K-Number: K213905 · 2022-08-25

ApplicantOrthonovis, Inc.
Decision Date2022-08-25
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ONX Large External Fixation System is a medical device manufactured by Orthonovis, Inc.. It received FDA 510(k) clearance on 2022-08-25 under approval number K213905. 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 ONX Large External Fixation System?

ONX Large External Fixation System is a medical device that received FDA 510(k) clearance on 2022-08-25. It is manufactured by Orthonovis, Inc.. The 510(k) number is K213905.

When was ONX Large External Fixation System approved by the FDA?

ONX Large External Fixation System received FDA 510(k) clearance on 2022-08-25, under approval number K213905.

What company makes ONX Large External Fixation System?

ONX Large External Fixation System is manufactured by Orthonovis, Inc..

What is the FDA product code for ONX Large External Fixation System?

The FDA product code for ONX Large External 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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