The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for R3 Xlpe Anteverted Liners.
| Device ID | K102370 |
| 510k Number | K102370 |
| Device Name: | R3 XLPE ANTEVERTED LINERS |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Megan Bevill |
| Correspondent | Megan Bevill SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | MBL |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-20 |
| Decision Date | 2011-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556712214 | K102370 | 000 |
| 00885556090060 | K102370 | 000 |
| 00885556090114 | K102370 | 000 |
| 00885556090169 | K102370 | 000 |
| 00885556090213 | K102370 | 000 |
| 00885556090268 | K102370 | 000 |
| 00885556090312 | K102370 | 000 |
| 00885556090367 | K102370 | 000 |
| 00885556090411 | K102370 | 000 |
| 00885556090466 | K102370 | 000 |
| 00885556090510 | K102370 | 000 |
| 00885556090015 | K102370 | 000 |