The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Concorde Vbr Spinal System.
| Device ID | K052746 |
| 510k Number | K052746 |
| Device Name: | CONCORDE VBR SPINAL SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Lisa Gilman |
| Correspondent | Lisa Gilman DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-30 |
| Decision Date | 2005-10-21 |
| Summary: | summary |