NUGEN FX SCREW

Screw, Fixation, Bone

BIONX IMPLANTS, INC.

The following data is part of a premarket notification filed by Bionx Implants, Inc. with the FDA for Nugen Fx Screw.

Pre-market Notification Details

Device IDK023022
510k NumberK023022
Device Name:NUGEN FX SCREW
ClassificationScrew, Fixation, Bone
Applicant BIONX IMPLANTS, INC. 1777 SENTRY PKWY. WEST, GWYNEDD HALL, SUITE 400 Blue Bell,  PA  19422
ContactGerard S Carlozzi
CorrespondentGerard S Carlozzi
BIONX IMPLANTS, INC. 1777 SENTRY PKWY. WEST, GWYNEDD HALL, SUITE 400 Blue Bell,  PA  19422
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-11
Decision Date2002-10-04
Summary:summary

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