DARCO HEADLESS COMPRESSION SCREW

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 Darco Headless Compression Screw.

Pre-market Notification Details

Device IDK080850
510k NumberK080850
Device Name:DARCO HEADLESS COMPRESSION SCREW
ClassificationScrew, Fixation, Bone
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
ContactTheresa Leister
CorrespondentTheresa Leister
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 Received2008-03-26
Decision Date2008-04-10
Summary:summary

NIH GUDID Devices

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