Ignite Anatomic Shoulder System

Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

Ignite Orthopedics LLC

The following data is part of a premarket notification filed by Ignite Orthopedics Llc with the FDA for Ignite Anatomic Shoulder System.

Pre-market Notification Details

Device IDK202716
510k NumberK202716
Device Name:Ignite Anatomic Shoulder System
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Applicant Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake,  IN  46590
ContactMatt Purdy
CorrespondentRuss Parrott
Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake,  IN  46590
Product CodeMBF  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
Subsequent Product CodeKWT
Subsequent Product CodePAO
CFR Regulation Number888.3670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-17
Decision Date2021-05-20

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