K200665 is an FDA 510(k) clearance for the VERASENSE for Stryker Triathlon. 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 April 12, 2020, 30 days after receiving the submission on March 13, 2020.
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 | K200665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2020 |
| Decision Date | April 12, 2020 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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. |