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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K253093
Device Name Vital™ Spinal Fixation System
Applicant
Highridge Medical, LLC
10225 Westmoor Dr.
Westminister,  CO  80021
Applicant Contact Eliot Teal
Correspondent
Highridge Medical, LLC
10225 Westmoor Dr.
Westminister,  CO  80021
Correspondent Contact Eliot Teal
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received09/23/2025
Decision Date 12/17/2025
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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