The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Legion Porous Cr Narrow Femoral Components.
| Device ID | K210566 |
| 510k Number | K210566 |
| Device Name: | LEGION Porous CR Narrow Femoral Components |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
| Contact | Michelle Huettner |
| Correspondent | Michelle Huettner Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-26 |
| Decision Date | 2021-03-25 |