The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Redapt Blade Augments.
| Device ID | K190847 |
| 510k Number | K190847 |
| Device Name: | REDAPT Blade Augments |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
| Contact | Konrad Wolfmeyer |
| Correspondent | Konrad Wolfmeyer Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-01 |
| Decision Date | 2019-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556587454 | K190847 | 000 |
| 00885556315743 | K190847 | 000 |
| 00885556315798 | K190847 | 000 |
| 00885556315842 | K190847 | 000 |
| 00885556315897 | K190847 | 000 |
| 00885556315941 | K190847 | 000 |
| 00885556586099 | K190847 | 000 |
| 00885556586105 | K190847 | 000 |
| 00885556586112 | K190847 | 000 |
| 00885556587430 | K190847 | 000 |
| 00885556315699 | K190847 | 000 |