K014200 is an FDA 510(k) clearance for the OPTIMESH. This device is classified as a Mesh, Surgical, Metal (Class II - Special Controls, product code EZX).
Submitted by Spineology, Inc. (Stillwater, US). The FDA issued a Cleared decision on November 26, 2003, 705 days after receiving the submission on December 21, 2001.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K014200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | December 21, 2001 |
| Decision Date | November 26, 2003 |
| Days to Decision | 705 days |
| Submission Type | Traditional |
| 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 |