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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K153575
Device Name Tyber Medical Trauma Screw
Applicant
TYBER MEDICAL LLC
89 HEADQUARTERS PLAZA NORTH
#1464
MORRISTOWN,  NJ  07960
Applicant Contact Mark F Schenk
Correspondent
TYBER MEDICAL LLC
89 HEADQUARTERS PLAZA NORTH
#1464
MORRISTOWN,  NJ  07960
Correspondent Contact Mark F Schenk
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/15/2015
Decision Date 02/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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