ExsoMed INnate NanoTM Lag Screw System

Screw, Fixation, Bone

ExsoMed Corp.

The following data is part of a premarket notification filed by Exsomed Corp. with the FDA for Exsomed Innate Nanotm Lag Screw System.

Pre-market Notification Details

Device IDK220892
510k NumberK220892
Device Name:ExsoMed INnate NanoTM Lag Screw System
ClassificationScrew, Fixation, Bone
Applicant ExsoMed Corp. 135 Columbia, Suite 201 Aliso Viejo,  CA  92656
ContactReinhold Toerek
CorrespondentReinhold Toerek
ExsoMed Corp. 135 Columbia, Suite 201 Aliso Viejo,  CA  92656
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-28
Decision Date2022-04-27

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