RedPoint Medical's Better Bunion System

Orthopaedic Surgical Planning And Instrument Guides

Redpoint Medical, LLC

The following data is part of a premarket notification filed by Redpoint Medical, Llc with the FDA for Redpoint Medical's Better Bunion System.

Pre-market Notification Details

Device IDK220717
510k NumberK220717
Device Name:RedPoint Medical's Better Bunion System
ClassificationOrthopaedic Surgical Planning And Instrument Guides
Applicant Redpoint Medical, LLC 13326 West Road Carmel,  IN  46074
ContactJames Spitler
CorrespondentRobert A. Poggie
BioVera, Inc. 65 Promenade Saint Louis Notre-Dame-de-L'lle-Perrot,  CA J7V7P2
Product CodePBF  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-11
Decision Date2022-06-09

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