Nexta PEEK Hammertoe Correction 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 Nexta Peek Hammertoe Correction System.

Pre-market Notification Details

Device IDK211996
510k NumberK211996
Device Name:Nexta PEEK Hammertoe Correction 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 Received2021-06-28
Decision Date2021-09-23

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