The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Patient Matched Cutting Blocks.
| Device ID | K130708 |
| 510k Number | K130708 |
| Device Name: | SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Bradley Heil |
| Correspondent | Bradley Heil SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JWH |
| Subsequent Product Code | MBH |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-15 |
| Decision Date | 2013-12-11 |
| Summary: | summary |