The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Verilast Wear Claims For The Legion Primary Knee System.
| Device ID | K093746 |
| 510k Number | K093746 |
| Device Name: | VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis, TN 38116 |
| Contact | Jason Sells |
| Correspondent | Jason Sells SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis, TN 38116 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-04 |
| Decision Date | 2010-04-14 |
| Summary: | summary |