Omni Foot And Ankle Plating System

Plate, Fixation, Bone

Exremity Medical, LLC.

The following data is part of a premarket notification filed by Exremity Medical, Llc. with the FDA for Omni Foot And Ankle Plating System.

Pre-market Notification Details

Device IDK221362
510k NumberK221362
Device Name:Omni Foot And Ankle Plating System
ClassificationPlate, Fixation, Bone
Applicant Exremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany,  NJ  07054
ContactMary Hoffman
CorrespondentMary Hoffman
Exremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany,  NJ  07054
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-11
Decision Date2022-06-10

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