The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Visionaire Patient Matched Cutting Blocks.
| Device ID | K183010 |
| 510k Number | K183010 |
| Device Name: | Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Brad Sheals |
| Correspondent | Brad Sheals Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | JWH |
| Subsequent Product Code | MBH |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-31 |
| Decision Date | 2018-11-28 |
| Summary: | summary |