Revolution Radial Head

Prosthesis, Elbow, Hemi-, Radial, Polymer

Ignite Orthopedics, Inc.

The following data is part of a premarket notification filed by Ignite Orthopedics, Inc. with the FDA for Revolution Radial Head.

Pre-market Notification Details

Device IDK183618
510k NumberK183618
Device Name:Revolution Radial Head
ClassificationProsthesis, Elbow, Hemi-, Radial, Polymer
Applicant Ignite Orthopedics, Inc. 210 North Buffalo Street Warsaw,,  IN  46580
ContactRuss Parrott
CorrespondentRuss Parrott
Ignite Orthopedics, Inc. 210 North Buffalo Street Warsaw,,  IN  46580
Product CodeKWI  
CFR Regulation Number888.3170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-26
Decision Date2019-05-17
Summary:summary

NIH GUDID Devices

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