The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Modification To Surgical Titanium Mesh System.
| Device ID | K020522 |
| 510k Number | K020522 |
| Device Name: | MODIFICATION TO 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 | 2002-02-19 |
| Decision Date | 2002-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034036823 | K020522 | 000 |
| 10705034036885 | K020522 | 000 |
| 10705034036861 | K020522 | 000 |
| 10705034036854 | K020522 | 000 |