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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 K160646
Device Name XYcor® Expandable Spinal Spacer System
Applicant
Alphatec Spine, Inc
5818 El Camino Real
Carlsbad,  CA  92008
Applicant Contact Renee Murphy
Correspondent
Alphatec Spine, Inc
5818 El Camino Real
Carlsbad,  CA  92008
Correspondent Contact Renee L. Murphy
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received03/07/2016
Decision Date 08/24/2016
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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