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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 K170688
Device Name PIT’Stop® implant
Applicant
In2bones Sas
28 Chemin Du Petit Bois
Ecully,  FR 69130
Applicant Contact Morgane Grenier
Correspondent
Estrin Consulting Group,Llc
3100 N Leisure World Blvd., Apt.121
Silver Spring,  MD  20906
Correspondent Contact Norman F. Estrin
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/07/2017
Decision Date 11/28/2017
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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