The following data is part of a premarket notification filed by Implex Corp. with the FDA for The Trabecular Metal Reconstruction System, Model 10-340-xxxxx.
| Device ID | K040756 |
| 510k Number | K040756 |
| Device Name: | THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX |
| Classification | Mesh, Surgical |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Marci Halevi |
| Correspondent | Marci Halevi IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-24 |
| Decision Date | 2004-07-14 |
| Summary: | summary |