ORTHOLOC 2 With 3Di Technology Pilon Fracture Plating System

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 Ortholoc 2 With 3di Technology Pilon Fracture Plating System.

Pre-market Notification Details

Device IDK201259
510k NumberK201259
Device Name:ORTHOLOC 2 With 3Di Technology Pilon Fracture Plating System
ClassificationPlate, Fixation, Bone
Applicant Wright Medical Technology, Inc. 1023 Cherry Road Memphis,  TN  38117
ContactAnna Hinton
CorrespondentAnna Hinton
Wright Medical Technology, Inc. 1023 Cherry Road Memphis,  TN  38117
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-11
Decision Date2021-01-08

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