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FDA 510(k)

OGmend® Implant Enhancement System

K-Number: K233223 · 2023-10-26

ApplicantWoven Orthopedic Technologies
Decision Date2023-10-26
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 2023-10-26 under approval 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. It is manufactured by Woven Orthopedic Technologies. The 510(k) number is K233223.

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

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

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

NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT06100393 New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients. ACTIVE_NOT_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05855135 Assessment of Combined CCM and ICD Device in HFrEF ACTIVE_NOT_RECRUITING

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

K223075Ogmend® Implant Enhancement System

Related Devices (Code: QVI)

K223075Ogmend® 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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