The following data is part of a premarket notification filed by Omnllife Science Inc. with the FDA for Omnibotics Knee System.
| Device ID | K163338 |
| 510k Number | K163338 |
| Device Name: | OMNIBotics Knee System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | OMNllife Science Inc. 480 Paramount Drive Raynham, MA 02767 |
| Contact | Daniel Decruppe |
| Correspondent | Christina Rovaldi OMNllife Science Inc. 480 Paramount Drive Raynham, MA 02767 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-28 |
| Decision Date | 2017-09-01 |
| Summary: | summary |