CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116

Fastener, Fixation, Biodegradable, Soft Tissue

BIONX IMPLANTS, INC.

The following data is part of a premarket notification filed by Bionx Implants, Inc. with the FDA for Contour Meniscus Arrow, Models 541110, 541113, And 541116.

Pre-market Notification Details

Device IDK012334
510k NumberK012334
Device Name:CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant BIONX IMPLANTS, INC. HERMIANKATU 6-8 L Tampere,  FI Fin-33720
ContactTuija Annala
CorrespondentTuija Annala
BIONX IMPLANTS, INC. HERMIANKATU 6-8 L Tampere,  FI Fin-33720
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-24
Decision Date2001-09-19
Summary:summary

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