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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 the device name listed in this FDA 510(k) record. The listed applicant is Orthonovis, Inc.. It received FDA 510(k) clearance on 2022-08-25 under 510(k) 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. The listed applicant is Orthonovis, Inc.. The 510(k) number is K213905.

When did ONX Large External Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for ONX Large External Fixation System?

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

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

The FDA product code for ONX Large External Fixation System is KTT.

Other records listing Orthonovis, 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.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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