The following data is part of a premarket notification filed by Corin Ltd. with the FDA for Omnibotics Knee System.
| Device ID | K200888 |
| 510k Number | K200888 |
| Device Name: | OMNIBotics Knee System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Corin Ltd. 480 Paramount Drive Raynham, MA 02767 |
| Contact | Christina Rovaldi |
| Correspondent | Robert A. Poggie Bio Vera Inc. 65 Promenade Saint Louis Notre Dame De Lile Perrot, CA J7v7p2 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-03 |
| Decision Date | 2020-06-27 |