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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K100147
Device Name S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
Applicant
AESCULAP IMPLANT SYSTEM, INC.
3773 CORPORATE PWKY.
CENTER VALLEY,  PA  18034
Applicant Contact Lisa Boyle
Correspondent
AESCULAP IMPLANT SYSTEM, INC.
3773 CORPORATE PWKY.
CENTER VALLEY,  PA  18034
Correspondent Contact Lisa Boyle
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNI  
Date Received01/19/2010
Decision Date 07/23/2010
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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