The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Stryker Spine Vertebral Body Support System.
| Device ID | K033837 |
| 510k Number | K033837 |
| Device Name: | STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-10 |
| Decision Date | 2004-01-08 |
| Summary: | summary |