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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name posterior cervical screw system
510(k) Number K213871
Device Name Ennovate Cervical Spinal and Occiput System
Applicant
Aesculap Implant Systems, LLC.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact Paul Amudala
Correspondent
Aesculap Implant Systems, LLC.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact Paul Amudala
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received12/13/2021
Decision Date 07/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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