Medartis Inc. ARC-1008K Arcus Staple System

Tinted Liquid

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

SUTURE ANCHOR, PEEK SUTURETAK 3 X 12.2MM

Mini QUICKANCHOR Plus (Number 2/0 Suture) Size 2/0 (3 metric) ORTHOCORD braided composite suture, 18 Inches (45cm), double-armed V-5 needles and 2.0 x 9.7mm drill bit, with disposable inserter.

SUTURE ANCHOR, PEEK PUSHLOCK

OSTEORAPTOR CURVED 2.3 PLLA/HA SUTURE ANCHOR, WITH ONE ULTRABRAID No.2 SUTURE COBRAID-BLUE

Super QUICKANCHOR Plus Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), double-armed with CP-2 needles, with disposable inserter.

GII QUICKANCHOR Plus Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), double-armed with CP-2 needles, with disposable inserter.

Tinted Liquid

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.