The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Simplex P Speedset With Tobramycin Bone Cement.
| Device ID | K063857 |
| 510k Number | K063857 |
| Device Name: | SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT |
| Classification | Bone Cement, Antibiotic |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 CORPORATE DR Mahwah, NJ 07430 |
| Contact | Tiffani Rogers |
| Correspondent | Tiffani Rogers HOWMEDICA OSTEONICS CORP. 325 CORPORATE DR Mahwah, NJ 07430 |
| Product Code | MBB |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-12-28 |
| Decision Date | 2007-02-26 |
| Summary: | summary |