The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Journey Ii Xr Knee Instruments.
| Device ID | K173331 |
| 510k Number | K173331 |
| Device Name: | JOURNEY II XR Knee Instruments |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Smith & Nephew, Inc. 1450 E. Brooks Road Memphis, TN 38116 |
| Contact | Shereen Bienz |
| Correspondent | Shereen Bienz Smith & Nephew, Inc. 1450 E. Brooks Road Memphis, TN 38116 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-23 |
| Decision Date | 2017-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556698020 | K173331 | 000 |
| 00885556696002 | K173331 | 000 |
| 00885556695999 | K173331 | 000 |
| 00885556695982 | K173331 | 000 |
| 00885556695975 | K173331 | 000 |
| 00885556695968 | K173331 | 000 |
| 00885556695951 | K173331 | 000 |
| 00885556695944 | K173331 | 000 |
| 00885556695937 | K173331 | 000 |
| 00885556696019 | K173331 | 000 |
| 00885556696026 | K173331 | 000 |
| 00885556698013 | K173331 | 000 |
| 00885556698006 | K173331 | 000 |
| 00885556697993 | K173331 | 000 |
| 00885556696088 | K173331 | 000 |
| 00885556696064 | K173331 | 000 |
| 00885556696057 | K173331 | 000 |
| 00885556696040 | K173331 | 000 |
| 00885556696033 | K173331 | 000 |
| 00885556687406 | K173331 | 000 |