The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Exeter X3 Rimfit Acetabular Cup.
| Device ID | K111848 |
| 510k Number | K111848 |
| Device Name: | EXETER X3 RIMFIT ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | STRYKER CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Estela Celi |
| Correspondent | Estela Celi STRYKER CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-29 |
| Decision Date | 2011-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327072396 | K111848 | 000 |
| 07613327072204 | K111848 | 000 |
| 07613327072198 | K111848 | 000 |
| 07613327072181 | K111848 | 000 |
| 07613327072174 | K111848 | 000 |
| 07613327072167 | K111848 | 000 |
| 07613327072150 | K111848 | 000 |
| 07613327072143 | K111848 | 000 |
| 07613327072136 | K111848 | 000 |
| 07613327072129 | K111848 | 000 |
| 07613327072112 | K111848 | 000 |
| 07613327072105 | K111848 | 000 |
| 07613327072211 | K111848 | 000 |
| 07613327072228 | K111848 | 000 |
| 07613327072235 | K111848 | 000 |
| 07613327072341 | K111848 | 000 |
| 07613327072334 | K111848 | 000 |
| 07613327072327 | K111848 | 000 |
| 07613327072310 | K111848 | 000 |
| 07613327072303 | K111848 | 000 |
| 07613327072297 | K111848 | 000 |
| 07613327072280 | K111848 | 000 |
| 07613327072273 | K111848 | 000 |
| 07613327072266 | K111848 | 000 |
| 07613327072259 | K111848 | 000 |
| 07613327072242 | K111848 | 000 |
| 07613327045383 | K111848 | 000 |