DuraStat

Durastat LLC · Model DUR-011 · UDI-DI 00850061177032

NBY Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

10-CT INNER PACK: DuraStat is a surgical device designed for dural repair in spine and cranial surgeries, enabling higher-quality, gold standard sutured closures with greater efficiency, especially in difficult-to-reach areas. It streamlines the repair process by combining a nerve hook and needle driver into one tool, automating suture passage with a button-press to eliminate supination and minimize tissue disruption. The device features a smooth, curved tip with a pre-loaded 5-0 PTFE suture and needle, allowing for precise, consistent placement and watertight closure to prevent persistent cerebrospinal fluid (CSF) leaks.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.