OGmend® Implant Enhancement System— 510(k) K233223

Name: FDA 510(k) clearance K233223
Creator: U.S. Food and Drug Administration
Published: 2023-10-26

Substantially Equivalent

Woven Orthopedic Technologies

FDA 510(k) clearance K233223 for OGmend® Implant Enhancement System, Substantially Equivalent on 2023-10-26. Applicant: Woven Orthopedic Technologies. Device class: 2.

Clearance details

Applicant: Woven Orthopedic Technologies
Product code: Code QVI
Device class: Class 2
Regulation: 21 CFR 888.3043
Advisory panel: Orthopedic
Date received: 2023-09-28
Decision date: 2023-10-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Manchester, CT, US

Download summary PDF View on FDA.gov ↗

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