WishBone Medical Plate And Screw System

Screw, Fixation, Bone

WishBone Medical, Inc.

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

Pre-market Notification Details

Device IDK203467
510k NumberK203467
Device Name:WishBone Medical Plate And Screw System
ClassificationScrew, Fixation, Bone
Applicant WishBone Medical, Inc. 100 Capital Drive Warsaw,  IN  46582
ContactMary Wentorf
CorrespondentMary Wentorf
WishBone Medical, Inc. 100 Capital Drive Warsaw,  IN  46582
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-25
Decision Date2020-12-23

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