Axis Charcot Fixation System

Screw, Fixation, Bone

Extremity Medical, LLC.

The following data is part of a premarket notification filed by Extremity Medical, Llc. with the FDA for Axis Charcot Fixation System.

Pre-market Notification Details

Device IDK211261
510k NumberK211261
Device Name:Axis Charcot Fixation System
ClassificationScrew, Fixation, Bone
Applicant Extremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany,  NJ  07054
ContactMary Hoffman
CorrespondentMary Hoffman
Extremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany,  NJ  07054
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-26
Decision Date2021-05-28

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