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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K012773
Device Name DISCOVERY FACET SCREW FIXATION SYSTEM
Applicant
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact KAREN F JURCZAK
Correspondent
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact KAREN F JURCZAK
Classification Product Code
MRW  
Date Received08/20/2001
Decision Date 11/16/2001
Decision Substantially Equivalent (SESE)
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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