K180459 is an FDA 510(k) clearance for the VERASENSE for Zimmer Biomet Persona. This device is classified as a Intraoperative Orthopedic Joint Assessment Aid (Class II - Special Controls, product code ONN).
Submitted by Orthosensor, Inc. (Dania Beach, US). The FDA issued a Cleared decision on June 7, 2018, 107 days after receiving the submission on February 20, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560. Measurement And Interpretation Of Orthopedic Joint Information..
| 510(k) Number | K180459 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2018 |
| Decision Date | June 07, 2018 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | ONN — Intraoperative Orthopedic Joint Assessment Aid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | Measurement And Interpretation Of Orthopedic Joint Information. |