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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 K123206
Device Name MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM
Applicant
Maxim Surgical
1565 N. Central Expy.
Suite 200
Richardson,  TX  75080
Applicant Contact CHRIS REEG
Correspondent
Maxim Surgical
1565 N. Central Expy.
Suite 200
Richardson,  TX  75080
Correspondent Contact CHRIS REEG
Regulation Number888.3080
Classification Product Code
ODP  
Date Received10/12/2012
Decision Date 02/07/2013
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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