The following data is part of a premarket notification filed by Omni Life Science, Inc. with the FDA for Tibial Baseplate Augment Model Kc-22118, Kc-22128, Kc-22138, Kc-22148, Kc-22158.
| Device ID | K094017 |
| 510k Number | K094017 |
| Device Name: | TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | OMNI LIFE SCIENCE, INC. 175 PARAMOUNT DRIVE Raynham, MA 02767 |
| Contact | Robert Zoletti |
| Correspondent | Robert Zoletti OMNI LIFE SCIENCE, INC. 175 PARAMOUNT DRIVE Raynham, MA 02767 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-29 |
| Decision Date | 2010-03-05 |
| Summary: | summary |