Nextra CH Cannulated Hammertoe System

Screw, Fixation, Bone

Nextremity Solutions, Inc.

The following data is part of a premarket notification filed by Nextremity Solutions, Inc. with the FDA for Nextra Ch Cannulated Hammertoe System.

Pre-market Notification Details

Device IDK221610
510k NumberK221610
Device Name:Nextra CH Cannulated Hammertoe System
ClassificationScrew, Fixation, Bone
Applicant Nextremity Solutions, Inc. 1195 Polk Drive Warsaw,  IN  46582
ContactElise Fox
CorrespondentElise Fox
Nextremity Solutions, Inc. 1195 Polk Drive Warsaw,  IN  46582
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-03
Decision Date2022-11-04

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