The following data is part of a premarket notification filed by Redpoint Medical, Llc with the FDA for Redpoint Medical's Better Bunion System.
Device ID | K220717 |
510k Number | K220717 |
Device Name: | RedPoint Medical's Better Bunion System |
Classification | Orthopaedic Surgical Planning And Instrument Guides |
Applicant | Redpoint Medical, LLC 13326 West Road Carmel, IN 46074 |
Contact | James Spitler |
Correspondent | Robert A. Poggie BioVera, Inc. 65 Promenade Saint Louis Notre-Dame-de-L'lle-Perrot, CA J7V7P2 |
Product Code | PBF |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-11 |
Decision Date | 2022-06-09 |