5TH METATARSAL FRACTURE 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 5th Metatarsal Fracture Screw.

Pre-market Notification Details

Device IDK053136
510k NumberK053136
Device Name:5TH METATARSAL FRACTURE SCREW
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-09
Decision Date2006-01-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420135001 K053136 000
00840420134998 K053136 000
00840420134981 K053136 000
00840420134974 K053136 000

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