Axis Plating System

Plate, Fixation, Bone

Extremity Medical, LLC.

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

Pre-market Notification Details

Device IDK192592
501k NumberK192592
Device Name:Axis Plating System
ClassificationPlate, Fixation, Bone
Applicant Extremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany,  NJ  07054
ContactBrian Smekal
CorrespondentBrian Smekal
Extremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany,  NJ  07054
Product CodeHRS  
Subsequent Product CodeHTN
Subsequent Product CodeHWC
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-20
Decision Date2019-11-21
Summary:summary

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.

A PHP Error was encountered

Severity: Core Warning

Message: Module 'zip' already loaded

Filename: Unknown

Line Number: 0

Backtrace: