The following data is part of a premarket notification filed by Omnlife Science with the FDA for Modification To: Apex Knee System.
| Device ID | K073602 |
| 510k Number | K073602 |
| Device Name: | MODIFICATION TO: APEX KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | OMNLIFE SCIENCE 175 PARAMOUNT DRIVE Raynham, MA 02767 |
| Contact | William Mccallum |
| Correspondent | William Mccallum OMNLIFE SCIENCE 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 | 2007-12-21 |
| Decision Date | 2008-02-14 |
| Summary: | summary |