Apollo Suture Anchor System

Fastener, Fixation, Nondegradable, Soft Tissue

Valeris Medical

The following data is part of a premarket notification filed by Valeris Medical with the FDA for Apollo Suture Anchor System.

Pre-market Notification Details

Device IDK192810
510k NumberK192810
Device Name:Apollo Suture Anchor System
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Valeris Medical 200 Cobb Pkwy N, Building 200, Suite 210 Marietta,  GA  30062
ContactBrendan Thies
CorrespondentBrendan Thies
Valeris Medical 200 Cobb Pkwy N, Building 200, Suite 210 Marietta,  GA  30062
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-01
Decision Date2020-03-11

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