The following data is part of a premarket notification filed by Orthosensor, Inc. with the FDA for Verasense For Zimmer Biomet Persona.
| Device ID | K180459 |
| 510k Number | K180459 |
| Device Name: | VERASENSE For Zimmer Biomet Persona |
| Classification | Intraoperative Orthopedic Joint Assessment Aid |
| Applicant | OrthoSensor, Inc. 1855 Griffin Road, Suite A-310 Dania Beach, FL 33004 |
| Contact | Deborah Johnson |
| Correspondent | Deborah 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-20 |
| Decision Date | 2018-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816818021461 | K180459 | 000 |
| 00816818021485 | K180459 | 000 |
| 00816818021492 | K180459 | 000 |
| 00816818021508 | K180459 | 000 |
| 00816818021515 | K180459 | 000 |
| 00816818021522 | K180459 | 000 |
| 00816818021416 | K180459 | 000 |
| 00816818021423 | K180459 | 000 |
| 00816818021430 | K180459 | 000 |
| 00816818021447 | K180459 | 000 |
| 00816818021454 | K180459 | 000 |
| 00816818021478 | K180459 | 000 |