Apollo Suture Anchor System And Titan Screws

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 And Titan Screws.

Pre-market Notification Details

Device IDK142230
510k NumberK142230
Device Name:Apollo Suture Anchor System And Titan Screws
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Valeris Medical 200 Cobb Pkw N,Bldg 200 Ste 210 Marietta,  GA  30062
ContactDaniel Lanois
CorrespondentCheryl L Wagoner
Wagoner Consulting LLC P O Box 15729 Wilmington,  NC  28408
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-13
Decision Date2014-09-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10818614021246 K142230 000
10818614020560 K142230 000
10818614020553 K142230 000
00818614020488 K142230 000
00818614020471 K142230 000
B048XTS65150 K142230 000
B048XTS55151 K142230 000
B048TS80120 K142230 000
B048TS70120 K142230 000

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