The following data is part of a premarket notification filed by Smith & Nephew Inc. with the FDA for Redapt Sleeved Monolithic Revision Stems.
| Device ID | K162303 |
| 510k Number | K162303 |
| Device Name: | REDAPT Sleeved Monolithic Revision Stems |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | SMITH & NEPHEW INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Kim Phan |
| Correspondent | Kim Phan SMITH & NEPHEW INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-17 |
| Decision Date | 2017-05-01 |
| Summary: | summary |