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 |