The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for R3 Multi-hole Shells And 36mm Xlpe Acetabular Liners.
| Device ID | K092386 |
| 510k Number | K092386 |
| Device Name: | R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR 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 | 2009-08-05 |
| Decision Date | 2009-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556113684 | K092386 | 000 |
| 00885556021491 | K092386 | 000 |
| 00885556021477 | K092386 | 000 |
| 00885556021255 | K092386 | 000 |
| 00885556021224 | K092386 | 000 |
| 00885556020968 | K092386 | 000 |
| 00885556020920 | K092386 | 000 |
| 00885556020814 | K092386 | 000 |
| 00885556020739 | K092386 | 000 |
| 00885556020692 | K092386 | 000 |
| 00885556020647 | K092386 | 000 |
| 00885556020630 | K092386 | 000 |
| 00885556020623 | K092386 | 000 |
| 00885556020364 | K092386 | 000 |
| 00885556020296 | K092386 | 000 |
| 00885556020210 | K092386 | 000 |
| 00885556019832 | K092386 | 000 |
| 00885556021583 | K092386 | 000 |
| 00885556021705 | K092386 | 000 |
| 00885556113677 | K092386 | 000 |
| 00885556113592 | K092386 | 000 |
| 00885556113585 | K092386 | 000 |
| 00885556113509 | K092386 | 000 |
| 00885556113271 | K092386 | 000 |
| 00885556113264 | K092386 | 000 |
| 00885556022672 | K092386 | 000 |
| 00885556022375 | K092386 | 000 |
| 00885556022214 | K092386 | 000 |
| 00885556022184 | K092386 | 000 |
| 00885556022153 | K092386 | 000 |
| 00885556021996 | K092386 | 000 |
| 00885556021941 | K092386 | 000 |
| 00885556021934 | K092386 | 000 |
| 00885556021804 | K092386 | 000 |
| 00885556021781 | K092386 | 000 |
| 00885556019795 | K092386 | 000 |