The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Legion Porous + Ha Tibial Baseplates.
| Device ID | K100897 |
| 510k Number | K100897 |
| Device Name: | LEGION POROUS + HA TIBIAL BASEPLATES |
| 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 | Megan Bevill |
| Correspondent | Megan Bevill SMITH & NEPHEW, INC. 1450 E 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 | 2010-03-31 |
| Decision Date | 2010-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556143476 | K100897 | 000 |
| 00885556143353 | K100897 | 000 |
| 00885556143360 | K100897 | 000 |
| 00885556143377 | K100897 | 000 |
| 00885556143384 | K100897 | 000 |
| 00885556143391 | K100897 | 000 |
| 00885556143407 | K100897 | 000 |
| 00885556143414 | K100897 | 000 |
| 00885556143421 | K100897 | 000 |
| 00885556143438 | K100897 | 000 |
| 00885556143445 | K100897 | 000 |
| 00885556143452 | K100897 | 000 |
| 00885556143469 | K100897 | 000 |
| 00885556143346 | K100897 | 000 |