The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Stryker Orthopaedics Hip Systems Labeling Update.
| Device ID | K153345 |
| 510k Number | K153345 |
| Device Name: | Stryker Orthopaedics Hip Systems Labeling Update |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Margaret Klippel |
| Correspondent | Margaret Klippel STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | LPH |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MAY |
| Subsequent Product Code | MBL |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-19 |
| Decision Date | 2016-05-25 |
| Summary: | summary |