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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, Cervical
510(k) Number K142345
Device Name Talos-C(HA) Cervical Intervertebral Body Fusion Devices
Applicant
Meditech Spine, LLC
1447 Peachtree St. NE Suite 44
Atlanta,  GA  30309
Applicant Contact JASON GROMEK
Correspondent
Meditech Spine, LLC
1447 Peachtree St. NE Suite 44
Atlanta,  GA  30309
Correspondent Contact JASON GROMEK
Regulation Number888.3080
Classification Product Code
ODP  
Date Received08/22/2014
Decision Date 02/22/2015
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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