K223227 is an FDA 510(k) clearance for the MAVEN™ Patient-Specific Instrumentation. This device is classified as a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code HSN).
Submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on November 17, 2022, 30 days after receiving the submission on October 18, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3110.
| 510(k) Number | K223227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2022 |
| Decision Date | November 17, 2022 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSN — Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3110 |