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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K132910
Device Name DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
Applicant
Synthes USA Products, LLC
1302 Wrights Ln. E.
West Chester,  PA  19380
Applicant Contact EUGENE BANG
Correspondent
Synthes USA Products, LLC
1302 Wrights Ln. E.
West Chester,  PA  19380
Correspondent Contact EUGENE BANG
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/17/2013
Decision Date 12/16/2013
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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