The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Simplex X.
| Device ID | K032945 |
| 510k Number | K032945 |
| Device Name: | SIMPLEX X |
| Classification | Bone Cement |
| Applicant | STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Dannielle Wheeler |
| Correspondent | Dannielle Wheeler STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-22 |
| Decision Date | 2004-05-25 |
| Summary: | summary |