The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for R3 Large Head Liners.
| Device ID | K211330 |
| 510k Number | K211330 |
| Device Name: | R3 Large Head Liners |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Kayla Franklin |
| Correspondent | Kayla Franklin Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-03 |
| Decision Date | 2022-01-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556776155 | K211330 | 000 |
| 00885556776148 | K211330 | 000 |
| 00885556776131 | K211330 | 000 |
| 00885556776124 | K211330 | 000 |
| 00885556776117 | K211330 | 000 |
| 00885556776100 | K211330 | 000 |