GENESYS PRESSFT SUTURE ANCHOR

Fastener, Fixation, Biodegradable, Soft Tissue

LINVATEC CORPORATION D/B/A CONMED LINVATEC

The following data is part of a premarket notification filed by Linvatec Corporation D/b/a Conmed Linvatec with the FDA for Genesys Pressft Suture Anchor.

Pre-market Notification Details

Device IDK121890
510k NumberK121890
Device Name:GENESYS PRESSFT SUTURE ANCHOR
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard Largo,  FL  33773
ContactLorna K Linville
CorrespondentLorna K Linville
LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard Largo,  FL  33773
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-28
Decision Date2012-08-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20845854051167 K121890 000
10845854027899 K121890 000
10845854027868 K121890 000
30845854027893 K121890 000
30845854027862 K121890 000
10845854027905 K121890 000
10845854027882 K121890 000
10845854027875 K121890 000
10845854027851 K121890 000

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