The following data is part of a premarket notification filed by Omnilife Science Inc. with the FDA for Apex Ps Knee System - Ps-c Insert.
| Device ID | K111184 |
| 510k Number | K111184 |
| Device Name: | APEX PS KNEE SYSTEM - PS-C INSERT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | OMNILIFE SCIENCE INC. 50 O'CONNELL WAY East Taunton, MA 02718 |
| Contact | Radhika Pondicherry |
| Correspondent | Radhika Pondicherry OMNILIFE SCIENCE INC. 50 O'CONNELL WAY East Taunton, MA 02718 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-27 |
| Decision Date | 2011-06-22 |
| Summary: | summary |