BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM

Plate, Bone

BIONX IMPLANTS, INC.

The following data is part of a premarket notification filed by Bionx Implants, Inc. with the FDA for Biosorbfx 2.0/2.4 Orthognathic And Mandibular Fixation System.

Pre-market Notification Details

Device IDK982721
510k NumberK982721
Device Name:BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM
ClassificationPlate, Bone
Applicant BIONX IMPLANTS, INC. 555 13TH STREET, N.W. Washington,  DC  20004
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
BIONX IMPLANTS, INC. 555 13TH STREET, N.W. Washington,  DC  20004
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-04
Decision Date1999-02-17
Summary:summary

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