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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 K161597
Device Name Tyber Medical BioTy® Nanotopography Trauma Screw
Applicant
Tyber Medical, LLC
89 Headquarters Plz. N.
#1464
Morristown,  NJ  07960
Applicant Contact MARK F. SCHENK
Correspondent
Tyber Medical, LLC
89 Headquarters Plz. N.
#1464
Morristown,  NJ  07960
Correspondent Contact MARK F. SCHENK
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/09/2016
Decision Date 11/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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