LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE

Plate, Bone

STRYKER LEIBINGER

The following data is part of a premarket notification filed by Stryker Leibinger with the FDA for Locking Screw Mandibular Reconstruction Plate.

Pre-market Notification Details

Device IDK000594
510k NumberK000594
Device Name:LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE
ClassificationPlate, Bone
Applicant STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo,  MI  49001
ContactRobin L Rowe
CorrespondentRobin L Rowe
STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo,  MI  49001
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-22
Decision Date2000-12-08

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