The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Disposable Fin Punch.
| Device ID | K141585 |
| 510k Number | K141585 |
| Device Name: | SMITH & NEPHEW DISPOSABLE FIN PUNCH |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Jenny Waldrip |
| Correspondent | Jenny Waldrip SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-13 |
| Decision Date | 2014-08-21 |
| Summary: | summary |