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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Instruments Designed For Use With Total Disc Replacement Devices
510(k) Number K241117
Device Name M6-C™ Single Use, Disposable Instrumentation
Applicant
Spinal Kinetics / Orthofix / Seaspine
501 Mercury Dr.
Sunnyvale,  CA  94085
Applicant Contact Tony John
Correspondent
Spinal Kinetics / Orthofix / Seaspine
501 Mercury Dr.
Sunnyvale,  CA  94085
Correspondent Contact Tony John
Classification Product Code
QLQ  
Date Received04/23/2024
Decision Date 06/21/2024
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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