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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 K160174
Device Name I.B.S. 2.0 Osteosynthesis screw
Applicant
In2bones Sas
28 Chemin Du Petit Bois
Ecully,  FR 69130
Applicant Contact Morgane Grenier
Correspondent
Estrin Consulting Group,Llc
9109 Copenhaver Dr.
Potomac,  MD  20854
Correspondent Contact Norman F Estrin
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/27/2016
Decision Date 10/06/2016
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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