510(k) K061487 ยท GXQ Dura Substitute
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
| Applicant | Collagen Matrix, Inc., Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Jun 26, 2006 |
| Received | May 31, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061487
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2022 | Collagen Matrix, Inc. DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm)
REF: CDSLM45 Terminated |
GXQ | None listed |
| Feb 24, 2022 | Collagen Matrix, Inc. RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter.
REF: DUMO10125 Terminated |
GXQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.