510(k) K092388 ยท GXQ Dura Substitute
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO
| Applicant | Integra LifeSciences Corporation, Planisboro NJ, US |
| Decision | Substantially Equivalent, Jan 21, 2010 |
| Received | Aug 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092388
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.