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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K250332
Device Name Virage® OCT Spinal Fixation System
Applicant
Highridge Medical, LLC
10225 Westmoor Dr.
Westminister,  CO  80021
Applicant Contact Regan Ream
Correspondent
Highridge Medical, LLC
10225 Westmoor Dr.
Westminister,  CO  80021
Correspondent Contact Regan Ream
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received02/05/2025
Decision Date 04/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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