FDA 510(k)

OGmend® Implant Enhancement System

K-Number: K233223 · 2023-10-26

Decision Date2023-10-26

Product CodeQVI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OGmend® Implant Enhancement System is the device name listed in this FDA 510(k) record. The listed applicant is Woven Orthopedic Technologies. It received FDA 510(k) clearance on 2023-10-26 under 510(k) number K233223. The device is classified under product code QVI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OGmend® Implant Enhancement System?

OGmend® Implant Enhancement System is a medical device that received FDA 510(k) clearance on 2023-10-26. The listed applicant is Woven Orthopedic Technologies. The 510(k) number is K233223.

When did OGmend® Implant Enhancement System receive FDA 510(k) clearance?

OGmend® Implant Enhancement System received FDA 510(k) clearance on 2023-10-26, under 510(k) number K233223.

Who is the listed applicant for OGmend® Implant Enhancement System?

The FDA 510(k) record lists Woven Orthopedic Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OGmend® Implant Enhancement System?

The FDA product code for OGmend® Implant Enhancement System is QVI.

Other records listing Woven Orthopedic Technologies 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.

K223075Ogmend® Implant Enhancement System

Related Devices (Code: QVI)

K223075Ogmend® Implant Enhancement SystemWoven Orthopedic Technologies

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.