K090474 is an FDA 510(k) clearance for the ORTHOREX INTRA-OPERATIVE LOAD SENSOR. This device is classified as a Intraoperative Orthopedic Joint Assessment Aid (Class II - Special Controls, product code ONN).
Submitted by Orthosensor, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on October 19, 2009, 237 days after receiving the submission on February 24, 2009.
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 | K090474 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2009 |
| Decision Date | October 19, 2009 |
| Days to Decision | 237 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. |