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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 K231769
Device Name activL® Next Generation Instrumentation
Applicant
Aesculap Implants Systems, LLC
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact Hamza Ahmed
Correspondent
Aesculap Implants Systems, LLC
3773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact Hamza Ahmed
Classification Product Code
QLQ  
Date Received06/16/2023
Decision Date 07/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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