The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Surgical Titanium Mesh System.
| Device ID | K030249 |
| 510k Number | K030249 |
| Device Name: | SURGICAL TITANIUM 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 | 2003-01-24 |
| Decision Date | 2003-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034118628 | K030249 | 000 |
| 10705034118505 | K030249 | 000 |
| 10705034118499 | K030249 | 000 |
| 10705034118789 | K030249 | 000 |
| 10705034118772 | K030249 | 000 |
| 10705034118765 | K030249 | 000 |
| 10705034118758 | K030249 | 000 |
| 10705034118741 | K030249 | 000 |
| 10705034118734 | K030249 | 000 |
| 10705034118727 | K030249 | 000 |
| 10705034118512 | K030249 | 000 |
| 10705034118529 | K030249 | 000 |
| 10705034118611 | K030249 | 000 |
| 10705034118604 | K030249 | 000 |
| 10705034118598 | K030249 | 000 |
| 10705034118581 | K030249 | 000 |
| 10705034118574 | K030249 | 000 |
| 10705034118567 | K030249 | 000 |
| 10705034118550 | K030249 | 000 |
| 10705034118543 | K030249 | 000 |
| 10705034118536 | K030249 | 000 |
| 10705034118710 | K030249 | 000 |