Overview: The document provides technical specifications and details for the KSS-II 5.5 Spinal Fixation System, which includes various types of pedicle screws and rods used in spinal surgeries. The system is compliant with ISO 13485 and FDA standards.
Specifications:- Pedicle Screws: The KSS 5.5 U Pedicle Screws are available in multiple variants, including standard, break-off, and multiaxial break-off types. They are made from titanium alloy and come in various diameters (4.0 mm to 7.0 mm) and lengths (25 mm to 55 mm).
- Rods and Crosslinks: The system includes 5.5 mm rods and crosslinks, also made from titanium alloy, with lengths ranging from 60 mm to 200 mm.
Components:- Rod 5.5 T6241: Used for posterior fixation.
- EF 5.5 Crosslinks T6290: Provides additional stability.
- Double and Single Rod Shims: Available for both anterior and posterior fixation.
Product Numbers: Each component and variant has a specific product number for identification and ordering purposes, such as T6214025 for a specific pedicle screw.
Material: All components are primarily made from titanium alloy, known for its strength and biocompatibility.
Applications: The KSS-II 5.5 system is designed for spinal fixation procedures, providing stability and support for spinal segments.
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