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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw Sleeve Bone Fixation Device, Spine
510(k) Number K223075
Device Name Ogmend® Implant Enhancement System
Applicant
Woven Orthopedic Technologies
63 Center Street #3a
Manchester,  CT  06040
Applicant Contact Brandon Bendes
Correspondent
Woven Orthopedic Technologies
63 Center Street #3a
Manchester,  CT  06040
Correspondent Contact Brandon Bendes
Regulation Number888.3043
Classification Product Code
QVI  
Date Received09/30/2022
Decision Date 02/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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