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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 K142589
Device Name Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL
Applicant
TITAN SPINE, LLC
6140 WEST EXECUTIVE DRIVE, SUITE A
MEQUON,  WI  53092
Applicant Contact Jane Rodd
Correspondent
MEMPHIS REGULATORY CONSULTING, LLC
3416 ROXEE RUN COVE
BARTLETT,  TN  38133
Correspondent Contact Kimberly Strohkirch
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
MQP   ODP   OVD  
Date Received09/15/2014
Decision Date 10/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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