The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Redapt Modular Acetabular Shell.
| Device ID | K182109 |
| 510k Number | K182109 |
| Device Name: | REDAPT Modular Acetabular Shell |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Meenakshi Gupta |
| Correspondent | Meenakshi Gupta Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-03 |
| Decision Date | 2018-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556657966 | K182109 | 000 |
| 00885556657805 | K182109 | 000 |
| 00885556657812 | K182109 | 000 |
| 00885556657836 | K182109 | 000 |
| 00885556657843 | K182109 | 000 |
| 00885556657850 | K182109 | 000 |
| 00885556657867 | K182109 | 000 |
| 00885556657874 | K182109 | 000 |
| 00885556657881 | K182109 | 000 |
| 00885556657898 | K182109 | 000 |
| 00885556657904 | K182109 | 000 |
| 00885556657911 | K182109 | 000 |
| 00885556657928 | K182109 | 000 |
| 00885556657935 | K182109 | 000 |
| 00885556657942 | K182109 | 000 |
| 00885556657959 | K182109 | 000 |
| 00885556657799 | K182109 | 000 |