LEE PLATE

Plate, Bone

HOWMEDICA LEIBINGER, INC.

The following data is part of a premarket notification filed by Howmedica Leibinger, Inc. with the FDA for Lee Plate.

Pre-market Notification Details

Device IDK970911
510k NumberK970911
Device Name:LEE PLATE
ClassificationPlate, Bone
Applicant HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas,  TX  75244
ContactKristyn Waski
CorrespondentKristyn Waski
HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas,  TX  75244
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-12
Decision Date1997-04-11
Summary:summary

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