510(k) K260317

Device

Artelon Convenience Kits

Applicant

International Life Sciences

510(k) number

K260317

Product code

QWJ

Decision

Substantially Equivalent (SESE)

Decision date

2026-04-09

Date received

2026-01-30

Regulation

878.3300

Classification name

Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament

Medical specialty

General, Plastic Surgery

Review panel

General, Plastic Surgery

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N