The following data is part of a premarket notification filed by Orthosensor, Inc. with the FDA for Verasense For Stryker Triathlon.
| Device ID | K200665 |
| 510k Number | K200665 |
| Device Name: | VERASENSE For Stryker Triathlon |
| Classification | Intraoperative Orthopedic Joint Assessment Aid |
| Applicant | OrthoSensor, Inc. 1855 Griffin Road Suite A-310 Dania Beach, FL 33004 |
| Contact | Deborah Escobar Johnson |
| Correspondent | Deborah Escobar Johnson OrthoSensor, Inc. 1855 Griffin Road Suite A-310 Dania Beach, FL 33004 |
| Product Code | ONN |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-13 |
| Decision Date | 2020-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816818022635 | K200665 | 000 |
| 00816818022536 | K200665 | 000 |
| 07613327581843 | K200665 | 000 |
| 00816818021584 | K200665 | 000 |
| 00816818021577 | K200665 | 000 |
| 00816818021560 | K200665 | 000 |
| 00816818021553 | K200665 | 000 |
| 00816818021546 | K200665 | 000 |
| 00816818021539 | K200665 | 000 |