The following data is part of a premarket notification filed by Omni Life Science, Inc. with the FDA for Apex Knee System, Model Kc-230xy, Kc-240xy [ No Holes, 2 Holes].
| Device ID | K080842 |
| 510k Number | K080842 |
| Device Name: | APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | OMNI LIFE SCIENCE, INC. 175 PARAMOUNT DRIVE Raynham, MA 02767 |
| Contact | William Mccallum |
| Correspondent | William Mccallum OMNI LIFE SCIENCE, INC. 175 PARAMOUNT DRIVE Raynham, MA 02767 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-25 |
| Decision Date | 2008-05-23 |
| Summary: | summary |