The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Simplex P Bone Cement.
| Device ID | K062553 |
| 510k Number | K062553 |
| Device Name: | SIMPLEX P BONE CEMENT |
| Classification | Bone Cement |
| Applicant | STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Tiffani D Rogers |
| Correspondent | Tiffani D Rogers STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-30 |
| Decision Date | 2007-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327128445 | K062553 | 000 |
| 57613327128432 | K062553 | 000 |