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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K103034
Device Name GENESYS SPINE INTERBODY FUSION SYSTEM
Applicant
GENESYS SPINE
1250 CAPITAL OF TEXAS HWY SO.
BUILDING THREE, SUITE 600
AUSTIN,  TX  78746
Applicant Contact JOSH KAUFMANN
Correspondent
GENESYS SPINE
1250 CAPITAL OF TEXAS HWY SO.
BUILDING THREE, SUITE 600
AUSTIN,  TX  78746
Correspondent Contact JOSH KAUFMANN
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
MQP   ODP  
Date Received10/13/2010
Decision Date 12/10/2010
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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