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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K153700
Device Name Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments
Applicant
Aesculap Implant Systems, LLC
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact Paul Amudala
Correspondent
Aesculap Implant Systems, LLC
3773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact Paul Amudala
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
HAW  
Date Received12/23/2015
Decision Date 07/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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