PIT’Stop® Implant

Screw, Fixation, Bone

In2Bones SAS

The following data is part of a premarket notification filed by In2bones Sas with the FDA for Pit’stop® Implant.

Pre-market Notification Details

Device IDK170688
510k NumberK170688
Device Name:PIT’Stop® Implant
ClassificationScrew, Fixation, Bone
Applicant In2Bones SAS 28 Chemin Du Petit Bois Ecully,  FR 69130
ContactMorgane Grenier
CorrespondentNorman F. Estrin
Estrin Consulting Group LLC 3100 N. Leisure World Blvd., Apt. 121 Silver Spring,  MD  20906
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-07
Decision Date2017-11-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03760225713396 K170688 000
03760225713389 K170688 000
03760225713372 K170688 000
03760225713365 K170688 000
03760225713358 K170688 000
03760225713341 K170688 000
03760225713334 K170688 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.