SYNTHES BIORESORBABLE SUTURE ANCHOR

Fastener, Fixation, Biodegradable, Soft Tissue

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Bioresorbable Suture Anchor.

Pre-market Notification Details

Device IDK994161
510k NumberK994161
Device Name:SYNTHES BIORESORBABLE SUTURE ANCHOR
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-09
Decision Date2000-07-28
Summary:summary

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