K223421 is an FDA 510(k) clearance for the MedCAD AccuPlan Orthopedics System. This device is classified as a Orthopaedic Surgical Planning And Instrument Guides (Class II - Special Controls, product code PBF).
Submitted by Medcad (Dallas, US). The FDA issued a Cleared decision on September 20, 2023, 314 days after receiving the submission on November 10, 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 | K223421 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 2022 |
| Decision Date | September 20, 2023 |
| Days to Decision | 314 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. |