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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K021039
Device Name BOWTI ANTERIOR BUTTRESS STAPLE 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
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/01/2002
Decision Date 12/11/2002
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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