CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE

Plate, Fixation, Bone

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Charlotte Lisfranc Bone Screw, Charlotte Lisfranc Plate.

Pre-market Notification Details

Device IDK081374
510k NumberK081374
Device Name:CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE
ClassificationPlate, Fixation, Bone
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
ContactSarah Holtgrewe
CorrespondentSarah Holtgrewe
WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-16
Decision Date2008-09-09
Summary:summary

NIH GUDID Devices

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