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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 K141953
Device Name ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
Applicant
TITAN SPINE, LLC
3416 ROXEE RUN COVE
BARTLETT,  TN  38133
Applicant Contact CHRISTINE SCIFERT
Correspondent
TITAN SPINE, LLC
3416 ROXEE RUN COVE
BARTLETT,  TN  38133
Correspondent Contact CHRISTINE SCIFERT
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
MQP   ODP   OVD  
Date Received07/18/2014
Decision Date 10/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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