The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Series Ii X3 Large Diameter Accetabular Inserts.
| Device ID | K103124 |
| 510k Number | K103124 |
| Device Name: | SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | STRYKER CORPORATION 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Estela Celi |
| Correspondent | Estela Celi STRYKER CORPORATION 325 Corporate Drive Mahwah, NJ 07430 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-22 |
| Decision Date | 2010-11-19 |
| Summary: | summary |