Ignite Stemless Anatomic Shoulder System

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained

Ignite Orthopedics LLC

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

Pre-market Notification Details

Device IDK203108
510k NumberK203108
Device Name:Ignite Stemless Anatomic Shoulder System
ClassificationProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Applicant Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake,  IN  46590
ContactMatt Purdy
CorrespondentRuss Parott
Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake,  IN  46590
Product CodePKC  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-15
Decision Date2021-07-16

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.