K131767 is an FDA 510(k) clearance for the ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM. 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 November 8, 2013, 144 days after receiving the submission on June 17, 2013.
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 | K131767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2013 |
| Decision Date | November 08, 2013 |
| Days to Decision | 144 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. |