The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Legion Porous Plus Ha Primary Femoral Components.
| Device ID | K091543 |
| 510k Number | K091543 |
| Device Name: | LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, 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 | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-26 |
| Decision Date | 2009-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556108604 | K091543 | 000 |
| 00885556108482 | K091543 | 000 |
| 00885556108499 | K091543 | 000 |
| 00885556108505 | K091543 | 000 |
| 00885556108512 | K091543 | 000 |
| 00885556108529 | K091543 | 000 |
| 00885556108536 | K091543 | 000 |
| 00885556108543 | K091543 | 000 |
| 00885556108550 | K091543 | 000 |
| 00885556108567 | K091543 | 000 |
| 00885556108574 | K091543 | 000 |
| 00885556108581 | K091543 | 000 |
| 00885556108598 | K091543 | 000 |
| 00885556108475 | K091543 | 000 |