The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Devex Mesh System.
| Device ID | K023835 |
| 510k Number | K023835 |
| Device Name: | DEVEX MESH SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Karen F Jurczak |
| Correspondent | Karen F Jurczak DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-18 |
| Decision Date | 2003-01-29 |
| Summary: | summary |