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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 K221403
Device Name Cortera Spinal Fixation System
Applicant
Surgalign Spine Technologies
520 Lake Cook Rd. Suite 315
Deerfield,  IL  60015
Applicant Contact Jessica Jho
Correspondent
Surgalign Spine Technologies
520 Lake Cook Rd. Suite 315
Deerfield,  IL  60015
Correspondent Contact Jessica Jho
Regulation Number888.3070
Classification Product Code
NKB  
Date Received05/16/2022
Decision Date 08/19/2022
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
Recalls CDRH Recalls
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