FIXIT Threaded Anchor System

Fastener, Fixation, Biodegradable, Soft Tissue

S.B.M SAS Science For Bio Materials

The following data is part of a premarket notification filed by S.b.m Sas Science For Bio Materials with the FDA for Fixit Threaded Anchor System.

Pre-market Notification Details

Device IDK170868
510k NumberK170868
Device Name:FIXIT Threaded Anchor System
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant S.B.M SAS Science For Bio Materials ZI Du Monge Lourdes,  FR 65100
ContactAnne Cospin-latapie
CorrespondentAnne Cospin-latapie
S.B.M SAS Science For Bio Materials ZI Du Monge Lourdes,  FR 65100
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-23
Decision Date2017-11-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03760154008921 K170868 000
03760154008273 K170868 000
03760154008280 K170868 000
03760154008211 K170868 000
03760154008228 K170868 000
03760154008235 K170868 000
03760154008846 K170868 000
03760154008860 K170868 000
03760154008884 K170868 000
03760154008907 K170868 000
03760154008914 K170868 000
03760154008853 K170868 000

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