CurvaFix IM System

Screw, Fixation, Bone

CurvaFix, Inc.

The following data is part of a premarket notification filed by Curvafix, Inc. with the FDA for Curvafix Im System.

Pre-market Notification Details

Device IDK222505
510k NumberK222505
Device Name:CurvaFix IM System
ClassificationScrew, Fixation, Bone
Applicant CurvaFix, Inc. 1406 Place NE Suite 107 Bellevue,  WA  98007
ContactSteve Dimmer
CorrespondentLisa Pritchard
Duval & Associates, P.A. 825 Nicollet Mall Medical Arts Building Suite 1820 Minneapolis,  MN  55402
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-18
Decision Date2022-10-27

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