The following data is part of a premarket notification filed by Implex Corp. with the FDA for Modification To Hedrocel Trabecular Metal Reconstruction System.
| Device ID | K032282 |
| 510k Number | K032282 |
| Device Name: | MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM |
| 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 | 2003-07-24 |
| Decision Date | 2003-08-21 |
| Summary: | summary |