LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREW

Plate, Fixation, Bone

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Luhr Pan Fixation System Condensed Straight Plate, Y Plates And 1.5mm Bone Screw.

Pre-market Notification Details

Device IDK951415
510k NumberK951415
Device Name:LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREW
ClassificationPlate, Fixation, Bone
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactJohn Dichiara
CorrespondentJohn Dichiara
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-28
Decision Date1995-06-22

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