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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 K241494
Device Name Pantheon Pedicle Screw and Iliac Bolt Fixation System
Applicant
Pantheon Spinal
40132 Industrial Park Cir.
Suite #101
Georgetown,  TX  78626
Applicant Contact Scott Spann
Correspondent
Djj Consulting, LLC
425 Literary Rd. Suite 401
Cleveland,  OH  44113
Correspondent Contact Daniel Johnson
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   OUR  
Date Received05/28/2024
Decision Date 07/26/2024
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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