Paragon 28 APEX 3D Total Ankle Replacement System

Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

Paragon 28, Inc.

The following data is part of a premarket notification filed by Paragon 28, Inc. with the FDA for Paragon 28 Apex 3d Total Ankle Replacement System.

Pre-market Notification Details

Device IDK192994
510k NumberK192994
Device Name:Paragon 28 APEX 3D Total Ankle Replacement System
ClassificationProsthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Applicant Paragon 28, Inc. 4B Inverness Ct. E., STE 280 Englewood,  CO  80112
ContactEric Lintula
CorrespondentHollace Rhodes
MCRA, LLC 1050 K Street NW, Suite 1000 Washington,  DC  20001
Product CodeHSN  
CFR Regulation Number888.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-25
Decision Date2020-07-10

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