Smart Correction System

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

WishBone Medical, Inc.

The following data is part of a premarket notification filed by Wishbone Medical, Inc. with the FDA for Smart Correction System.

Pre-market Notification Details

Device IDK193368
510k NumberK193368
Device Name:Smart Correction System
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant WishBone Medical, Inc. 2150 North Pointe Drive Warsaw,  IN  46582
ContactMary Wentorf
CorrespondentMary Wentorf
WishBone Medical, Inc. 2150 North Pointe Drive Warsaw,  IN  46582
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-05
Decision Date2020-09-18

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