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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 K221848
Device Name prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
Applicant
Centinel Spine, LLC
900 Airport Rd., Suite 3b
West Chester,  PA  19380
Applicant Contact Jessica Staub
Correspondent
Mcra, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Classification Product Code
QLQ  
Date Received06/24/2022
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
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