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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 K130573
Device Name TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF
Applicant
Tyber Medical, LLC
89 Headquarters Plaza N.
#1464
Morristown,  NJ  07960
Applicant Contact JEFF TYBER
Correspondent
Tyber Medical, LLC
89 Headquarters Plaza N.
#1464
Morristown,  NJ  07960
Correspondent Contact JEFF TYBER
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received03/04/2013
Decision Date 09/30/2013
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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