SILKBridge— 510(k) K260245

SILKBridge is a neurosurgical or peripheral-nerve device — product code JXI is a Neurology panel code covering nerve repair and nerve-gap reconstruction devices. The "silk" naming suggests a silk-based biomaterial scaffold, a research area that's been slowly translating into clinical products.

Neurology panel, Traditional 510(k). JXI is a low-volume product code with a small predicate set — most cleared devices are variations on collagen, silk, or synthetic-polymer conduits for peripheral nerve repair.

KLISBio S.r.l. files from Bresso, Italy. Under-three-month review clock — short for a first-entrant biomaterial device on a small predicate set, which may indicate the substantial equivalence comparison landed cleanly against an existing nerve-conduit predicate.