K220717 is an FDA 510(k) clearance for the RedPoint Medical's Better Bunion System. This device is classified as a Orthopaedic Surgical Planning And Instrument Guides (Class II - Special Controls, product code PBF).
Submitted by Redpoint Medical, LLC (Carmel, US). The FDA issued a Cleared decision on June 9, 2022, 90 days after receiving the submission on March 11, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030. As A Surgical Instrument To Assist In Pre-operative Planning And/or Guiding The Marking Of Bone And/or Guide Surgical Instruments For Orthopedic Surgical Procedures..
| 510(k) Number | K220717 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2022 |
| Decision Date | June 09, 2022 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PBF - Orthopaedic Surgical Planning And Instrument Guides |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
| Definition | As A Surgical Instrument To Assist In Pre-operative Planning And/or Guiding The Marking Of Bone And/or Guide Surgical Instruments For Orthopedic Surgical Procedures. |