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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K242527
Device Name The Karma® Fixation System
Applicant
Spinal Elements, Inc.
3115 S. Melrose Suite 200
Carlsbad,  CA  92010
Applicant Contact Cheryl Allen
Correspondent
Spinal Elements, Inc.
3115 S. Melrose Suite 200
Carlsbad,  CA  92010
Correspondent Contact Cheryl Allen
Classification Product Code
MRW  
Date Received08/26/2024
Decision Date 05/21/2025
Decision Substantially Equivalent (SESE)
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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