DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE— 510(k) K061487
Substantially EquivalentCollagen Matrix, Inc.
FDA 510(k) clearance K061487 for DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE, Substantially Equivalent on 2006-06-26. Applicant: Collagen Matrix, Inc.. Device class: 2.
Clearance details
- Applicant
- Collagen Matrix, Inc.
- Product code
- Code GXQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5910
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Franklin Lakes, NJ, US
Recent devices under product code GXQ
view allMore clearances from Collagen Matrix, Inc.
view allAdverse events under product code GXQ
product code GXQ- Death
- 11
- Injury
- 446
- Other
- 1
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K061487
K-number listed on FDA's recall record- Z-0668-2022 — DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
- Z-0669-2022 — RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061487.
Data sourced from openFDA. This site is unofficial and independent of the FDA.