The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Surgical Titanium Mesh System.
| Device ID | K003043 |
| 510k Number | K003043 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-29 |
| Decision Date | 2001-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034036267 | K003043 | 000 |
| 10705034036120 | K003043 | 000 |
| 10705034036113 | K003043 | 000 |
| 10705034035987 | K003043 | 000 |
| 10705034018195 | K003043 | 000 |
| 10705034018188 | K003043 | 000 |
| 10705034018140 | K003043 | 000 |
| 10705034036489 | K003043 | 000 |
| 10705034036465 | K003043 | 000 |
| 10705034036229 | K003043 | 000 |
| 10705034036236 | K003043 | 000 |
| 10705034051437 | K003043 | 000 |
| 10705034036243 | K003043 | 000 |
| 10705034036212 | K003043 | 000 |
| 10705034036106 | K003043 | 000 |
| 10705034035994 | K003043 | 000 |
| 10705034035970 | K003043 | 000 |
| 10705034051482 | K003043 | 000 |
| 10705034051451 | K003043 | 000 |
| 10705034051444 | K003043 | 000 |
| 10705034017839 | K003043 | 000 |