MATRYX INTERFERENCE SCREW

Screw, Fixation, Bone

LINVATEC BIOMATERIALS, INC.

The following data is part of a premarket notification filed by Linvatec Biomaterials, Inc. with the FDA for Matryx Interference Screw.

Pre-market Notification Details

Device IDK052080
510k NumberK052080
Device Name:MATRYX INTERFERENCE SCREW
ClassificationScrew, Fixation, Bone
Applicant LINVATEC BIOMATERIALS, INC. P.O. BOX 3 HERMIANKATU 6-8L Tampere,  FI Fin-33720
ContactTuija Annala
CorrespondentTuija Annala
LINVATEC BIOMATERIALS, INC. P.O. BOX 3 HERMIANKATU 6-8L Tampere,  FI Fin-33720
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-02
Decision Date2005-08-25
Summary:summary

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