The following data is part of a premarket notification filed by Orthosensor, Inc. with the FDA for Orthosensor Knee Balancer, Verasense Knee System.
| Device ID | K131767 |
| 510k Number | K131767 |
| Device Name: | ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM |
| Classification | Intraoperative Orthopedic Joint Assessment Aid |
| Applicant | ORTHOSENSOR, INC. 1855 GRIFFIN ROAD SUITE A-310 Dania Beach, FL 33004 -2200 |
| Contact | Martha I Garay |
| Correspondent | Martha I Garay ORTHOSENSOR, INC. 1855 GRIFFIN ROAD SUITE A-310 Dania Beach, FL 33004 -2200 |
| Product Code | ONN |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-17 |
| Decision Date | 2013-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816818020624 | K131767 | 000 |
| 00816818020020 | K131767 | 000 |
| 00816818020037 | K131767 | 000 |
| 00816818020044 | K131767 | 000 |
| 00816818020051 | K131767 | 000 |
| 00816818020068 | K131767 | 000 |
| 00816818020570 | K131767 | 000 |
| 00816818020587 | K131767 | 000 |
| 00816818020594 | K131767 | 000 |
| 00816818020600 | K131767 | 000 |
| 00816818020617 | K131767 | 000 |
| 00816818020013 | K131767 | 000 |