ANATOMICAL BANKART TACK, MODEL 523520A

Fastener, Fixation, Biodegradable, Soft Tissue

BIONX IMPLANTS, LTD.

The following data is part of a premarket notification filed by Bionx Implants, Ltd. with the FDA for Anatomical Bankart Tack, Model 523520a.

Pre-market Notification Details

Device IDK992567
510k NumberK992567
Device Name:ANATOMICAL BANKART TACK, MODEL 523520A
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant BIONX IMPLANTS, LTD. P.O. BOX 3 HERMINKATU 6-8L Tampere,  FI Sp-33721
ContactTuija Annala
CorrespondentTuija Annala
BIONX IMPLANTS, LTD. P.O. BOX 3 HERMINKATU 6-8L Tampere,  FI Sp-33721
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-02
Decision Date1999-08-27
Summary:summary

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