The following data is part of a premarket notification filed by Omni Life Science, Inc. with the FDA for Omni Tin Coated Apex Knee™ System.
| Device ID | K191765 |
| 510k Number | K191765 |
| Device Name: | OMNI TiN Coated Apex Knee™ System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | OMNI Life Science, Inc. 480 Paramount Drive Raynham, MA 02767 |
| Contact | Christina Rovaldi |
| Correspondent | Christina Rovaldi OMNI Life Science, Inc. 480 Paramount Drive Raynham, MA 02767 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-01 |
| Decision Date | 2019-09-25 |
| Summary: | summary |