CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003

Screw, 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 Snap-off Screw, Models 45110001, 45110002, 45110003.

Pre-market Notification Details

Device IDK043583
510k NumberK043583
Device Name:CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003
ClassificationScrew, Fixation, Bone
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
ContactWesley L Reed
CorrespondentWesley L Reed
WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-28
Decision Date2005-01-26
Summary:summary

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