Omni Foot And Ankle 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 Omni Foot And Ankle Plating System.

Pre-market Notification Details

Device IDK212297
510k NumberK212297
Device Name:Omni Foot And Ankle 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  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-22
Decision Date2021-08-20

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