K032282 is an FDA 510(k) clearance for the MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM. This device is classified as a Mesh, Surgical, Metal (Class II - Special Controls, product code EZX).
Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on August 21, 2003, 28 days after receiving the submission on July 24, 2003.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K032282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2003 |
| Decision Date | August 21, 2003 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | EZX — Mesh, Surgical, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |