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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 K242869
Device Name prodisc® L Instruments
Applicant
Centinel Spine, LLC
900 Airport Rd., Suite 3b
West Chester,  PA  19380
Applicant Contact Jessica Staub
Correspondent
Centinel Spine, LLC
900 Airport Rd., Suite 3b
West Chester,  PA  19380
Correspondent Contact Jessica Staub
Classification Product Code
QLQ  
Date Received09/20/2024
Decision Date 12/17/2024
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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