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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 K173885
Device Name Genesys Spine Binary Lumbar Plate System
Applicant
Genesys Spine
1250 S. Capital Of Texas Hwy.
Bldg. 3, Suite 600
Austin,  TX  78746
Applicant Contact Brian J. Bergeron
Correspondent
Genesys Spine
1250 S. Capital Of Texas Hwy.
Bldg. 3, Suite 600
Austin,  TX  78746
Correspondent Contact William W Sowers
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/21/2017
Decision Date 04/03/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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