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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 K241892
Device Name Cortera™ Spinal Fixation System
Applicant
Xtant Medical Holdings, Inc.
664 Cruiser Ln.
Belgrade,  MT  59714
Applicant Contact Rebecca Lennemann
Correspondent
Xtant Medical Holdings, Inc.
664 Cruiser Ln.
Belgrade,  MT  59714
Correspondent Contact Rebecca Lennemann
Regulation Number888.3070
Classification Product Code
NKB  
Date Received06/28/2024
Decision Date 08/02/2024
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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