The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Journey Unicondylar Tibial Baseplates.
| Device ID | K102069 |
| 510k Number | K102069 |
| Device Name: | JOURNEY UNICONDYLAR TIBIAL BASEPLATES |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
| Contact | Gino Rouss |
| Correspondent | Gino Rouss SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-23 |
| Decision Date | 2010-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556088395 | K102069 | 000 |
| 00885556087893 | K102069 | 000 |
| 00885556087947 | K102069 | 000 |
| 00885556087992 | K102069 | 000 |
| 00885556088043 | K102069 | 000 |
| 00885556088098 | K102069 | 000 |
| 00885556088142 | K102069 | 000 |
| 00885556088197 | K102069 | 000 |
| 00885556088241 | K102069 | 000 |
| 00885556088296 | K102069 | 000 |
| 00885556088340 | K102069 | 000 |
| 00885556087848 | K102069 | 000 |