The following data is part of a premarket notification filed by Implex Corp. with the FDA for The Hedrocel Trabecular Metal Reconstruction System Model 10-330.
| Device ID | K032344 |
| 510k Number | K032344 |
| Device Name: | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 |
| Classification | Mesh, Surgical, Metal |
| 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 | EZX |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-30 |
| Decision Date | 2003-10-02 |
| Summary: | summary |