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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 K081770
Device Name BLACK WIDOW ANTERIOR BUTTRESS PLATE
Applicant
OMNI SURGICAL, L.P.
5000 PLAZA ON THE LAKE
SUITE 305
AUSTIN,  TX  78746
Applicant Contact JOSHUA KAUFMAN
Correspondent
OMNI SURGICAL, L.P.
5000 PLAZA ON THE LAKE
SUITE 305
AUSTIN,  TX  78746
Correspondent Contact JOSHUA KAUFMAN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/23/2008
Decision Date 04/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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