K260317

Artelon Convenience Kits are packaged surgical kits — product code QWJ covers soft-tissue reinforcement implants and related fixation hardware used in plastic, orthopedic, and general-surgery repairs. The "Convenience Kit" naming indicates a bundled SKU combining the implant with sutures, needles, or other delivery components.

General, Plastic Surgery panel, Traditional 510(k). Kit clearances for already-cleared base devices are common — the substantial equivalence argument is typically straightforward because the individual components are previously cleared.

International Life Sciences files from Sandy Springs, GA. Roughly two-month review clock. Artelon's fixation products for small-joint reconstruction are established in QWJ.