BLUE SHARK Blue Shark is supplied in a single use kit of two sterile blister packs including the following: ITEM NUMBER BLUE SHARK KIT Fixator and Instrumentation STERILE BLISTER FIXATOR PACK Anatomical stirrup, right Anatomical stirrup, left Arc, Large with clamp Arc, Small with clamp STERILE BLISTER INSTRUMENTATION PACK Q.TY Flat Wrench - 15 mm Cannula guide ITEM NUMBER Aluminum Arc T-Wrench Ø12 for Aluminum Arc Flat Wrench 12 mm Cortical Self-drilling Screws, Ø 6x200 MATERIALS Fixator Frame: High resistant polymeric composite Grasping Components: AISI 316LVM stainless steel; Conforms to ISO 5832-1 standards Arc Accessories: Aluminum 7012 Alloy PRODUCT IDENTIFICATION AND TRACEABILITY To assure traceability all of Mikai’s devices are identified by means of an item number and lot number and some products also use a series number. This information is indicated on the packaging and devices. MANUFACTURERS INFORMATION Blue Shark is manufactured by Mikai S.p.A. Blue Shark is a registered trademark of Mikai S.p.A. For the use of this device please consult the documentation provided by Mikai S.p.A. Mikai S.p.A. conforms to ISO 13485 standards CONTACTS : Headquarters: Mikai S.p.a. - Via P. Gobetti 56r 16145 Genova - Italy Tel.+39 010 3080.1 - Fax +39 010 3080.211 Manufacturer: Via Canestrello 2 36050 Monteviale (VI) - Italy Tel.+39 0444 950100 - Fax +39 0444 950133 www.mikai.it - [email protected]

DESCRIPTION OF COMPONENTS The Blue Shark radiolucent pelvic fixator for the pelvic ring was designed by the engineers at Mikai to mimic the anatomical structure of the pelvic girdle and developed using CAD/CAM software to project typical screw insertions. The conditions we sought to achieve in the realization of this fixator were: quick implant, minimal instrumentation, radiolucent, compatible with MRI and CT, adaptable to different patient anatomies, and no interference with potential abdominal or urological surgeries. Blue Shark is practical for surgeons in various hospital departments and...