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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 K133245
Device Name GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM
Applicant
GENESYS SPINE
1250 CAPITAL OF TEXAS HWY SOUTH
BUILDING THREE, SUITE 600
AUSTIN,  TX  78746
Applicant Contact WILLIAM W SOWERS
Correspondent
GENESYS SPINE
1250 CAPITAL OF TEXAS HWY SOUTH
BUILDING THREE, SUITE 600
AUSTIN,  TX  78746
Correspondent Contact WILLIAM W SOWERS
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/22/2013
Decision Date 10/08/2014
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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