The following data is part of a premarket notification filed by Orthosensor, Inc. with the FDA for Orthorex Intra-operative Load Sensor.
| Device ID | K090474 |
| 510k Number | K090474 |
| Device Name: | ORTHOREX INTRA-OPERATIVE LOAD SENSOR |
| Classification | Intraoperative Orthopedic Joint Assessment Aid |
| Applicant | ORTHOSENSOR, INC. 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Contact | Jon Ward |
| Correspondent | Jon Ward ORTHOSENSOR, INC. 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Product Code | ONN |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-24 |
| Decision Date | 2009-10-19 |
| Summary: | summary |