K092388 is an FDA 510(k) clearance for the DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO. This device is classified as a Dura Substitute (Class II - Special Controls, product code GXQ).
Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on January 21, 2010, 169 days after receiving the submission on August 5, 2009.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5910.
| 510(k) Number | K092388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2009 |
| Decision Date | January 21, 2010 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXQ — Dura Substitute |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5910 |