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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 K173832
Device Name InTice™-C Porous Ti Cervical Interbody System
Applicant
X-Spine Systems, Inc.
452 Alexandersville Rd.
Miamisburg,  OH  45342
Applicant Contact Charlene Brumbaugh
Correspondent
X-Spine Systems, Inc.
452 Alexandersville Rd.
Miamisburg,  OH  45342
Correspondent Contact Charlene Brumbaugh
Regulation Number888.3080
Classification Product Code
ODP  
Date Received12/18/2017
Decision Date 05/17/2018
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
Recalls CDRH Recalls
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