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FDA 510(k)

Ogmend® Implant Enhancement System

K-Number: K223075 · 2023-02-27

ApplicantWoven Orthopedic Technologies
Decision Date2023-02-27
Product CodeQVI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ogmend® Implant Enhancement System is a medical device manufactured by Woven Orthopedic Technologies. It received FDA 510(k) clearance on 2023-02-27 under approval number K223075. 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 2023-02-27. It is manufactured by Woven Orthopedic Technologies. The 510(k) number is K223075.

When was Ogmend® Implant Enhancement System approved by the FDA?

Ogmend® Implant Enhancement System received FDA 510(k) clearance on 2023-02-27, under approval number K223075.

What company makes Ogmend® Implant Enhancement System?

Ogmend® Implant Enhancement System is manufactured by Woven Orthopedic Technologies.

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Woven Orthopedic Technologies

K233223OGmend® Implant Enhancement System

Related Devices (Code: QVI)

K233223OGmend® Implant Enhancement SystemWoven Orthopedic Technologies

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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