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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 K201751
Device Name Pedicle Screw System
Applicant
Black Box Medical, LLC
4516 E. County Rd. 45
Midland,  TX  79705
Applicant Contact Todd Stanaford
Correspondent
Surgop Support, LLC
101 Lamond Ct.
Prosper,  TX  75078
Correspondent Contact Daniel Lanois
Regulation Number888.3070
Classification Product Code
NKB  
Date Received06/26/2020
Decision Date 07/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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