The following data is part of a premarket notification filed by Orthosensor, Inc. with the FDA for Verasense For Zimmer Biomet Persona Cr C-d/3-9 Left, Verasense For Zimmer Biomet Persona Cr C-d/3-9 Right, Verasense For Zimmer Biomet Persona Cr E-f/3-11 Left, Verasense For Zimmer Biomet Persona Cr E-f/3-11 Right, Verasense For Zimmer Biomet Person.
| Device ID | K193580 |
| 510k Number | K193580 |
| Device Name: | VERASENSE For Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE For Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE For Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE For Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE For Zimmer Biomet Person |
| 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 | 2019-12-23 |
| Decision Date | 2020-04-01 |