OTIS-C PLUS

Plate, Fixation, Bone

SCIENCE FOR BIOMATERIALS

The following data is part of a premarket notification filed by Science For Biomaterials with the FDA for Otis-c Plus.

Pre-market Notification Details

Device IDK120818
510k NumberK120818
Device Name:OTIS-C PLUS
ClassificationPlate, Fixation, Bone
Applicant SCIENCE FOR BIOMATERIALS ZI DU MONGE Lourdes,  FR F 65100
ContactDenis Clement
CorrespondentDenis Clement
SCIENCE FOR BIOMATERIALS ZI DU MONGE Lourdes,  FR F 65100
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-19
Decision Date2012-04-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03760154004794 K120818 000
03760154005135 K120818 000
03760154005142 K120818 000
03760154007924 K120818 000
03760154004145 K120818 000
03760154004152 K120818 000
03760154004169 K120818 000
03760154004190 K120818 000
03760154004459 K120818 000
03760154004480 K120818 000
03760154004497 K120818 000
03760154004695 K120818 000
03760154004701 K120818 000
03760154004718 K120818 000
03760154004732 K120818 000
03760154004749 K120818 000
03760154004756 K120818 000
03760154004770 K120818 000
03760154001397 K120818 000

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