The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Legion Porous Primary.
| Device ID | K073325 |
| 510k Number | K073325 |
| Device Name: | LEGION POROUS PRIMARY |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Rishi Sinha |
| Correspondent | Rishi Sinha SMITH & NEPHEW, INC. 1450 BROOKS RD. 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 | 2007-11-27 |
| Decision Date | 2007-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556032633 | K073325 | 000 |
| 00885556030684 | K073325 | 000 |
| 00885556030707 | K073325 | 000 |
| 00885556030769 | K073325 | 000 |
| 00885556030936 | K073325 | 000 |
| 00885556031063 | K073325 | 000 |
| 00885556031285 | K073325 | 000 |
| 00885556031384 | K073325 | 000 |
| 00885556031407 | K073325 | 000 |
| 00885556031520 | K073325 | 000 |
| 00885556031674 | K073325 | 000 |
| 00885556031964 | K073325 | 000 |
| 00885556032343 | K073325 | 000 |
| 00885556030394 | K073325 | 000 |