PROSTEP MICA Screw System

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 Prostep Mica Screw System.

Pre-market Notification Details

Device IDK181377
510k NumberK181377
Device Name:PROSTEP MICA Screw System
ClassificationScrew, Fixation, Bone
Applicant Wright Medical Technology, Inc. 1023 Cherry Road Memphis,  TN  38117
ContactVal Myles
CorrespondentVal Myles
Wright Medical Technology, Inc. 1023 Cherry Road Memphis,  TN  38117
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-24
Decision Date2019-01-11

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