The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Visionaire Uk Patient Matched Cutting Guides.
| Device ID | K211512 |
| 510k Number | K211512 |
| Device Name: | VISIONAIRE UK Patient Matched Cutting Guides |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Leah Hawkins |
| Correspondent | Leah Andre Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | HSX |
| Subsequent Product Code | JWH |
| Subsequent Product Code | MBH |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-14 |
| Decision Date | 2021-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556780039 | K211512 | 000 |
| 00885556779989 | K211512 | 000 |