K220830 is an FDA 510(k) clearance for the TrueBalance? Surgical System. This device is classified as a Intraoperative Orthopedic Joint Assessment Aid (Class II - Special Controls, product code ONN).
Submitted by These Three Medical, LLC (Phoenix, US). The FDA issued a Cleared decision on September 15, 2022, 177 days after receiving the submission on March 22, 2022.
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 | K220830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2022 |
| Decision Date | September 15, 2022 |
| Days to Decision | 177 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. |