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Manufacturer of orthopedic implants and surgical instruments based in Kladno, Czech Republic since 1992.
ChequiaFundada en 1992Fabricante · SaludISO 13485CE certification (Class I, IIb, III)ISO 9001
clinical evaluation
This document is a Summary of Safety and Clinical Performance (SSCP) for the trapeziometacarpal joint replacement device, providing information on clinical evaluation, safety, and performance data.
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Instructions for use for Beznoska cementless hip stems, including SF, RMD, and Trio models. Covers product descriptions, material specifications (ISO 5832-3, ISO 5832-2, ISO 13779-2, ISO 5832-12), indications, contraindications, surgical warnings, and post-operative care.
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Instructions for use for Beznoska cemented acetabular cups, covering handling, indications, contraindications, surgical procedure, and post-operative care. Includes information on sterility, material composition (UHMWPE and stainless steel), and compatibility with Beznoska hip heads.
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Instructions for use for Beznoska hip joint heads (metal and ceramic), covering indications, contraindications, surgical procedures, warnings, and sterilization information for total hip replacement systems.
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Instructions for use for the Beznoska Cervical-Capital Endoprosthesis product group, including stems, metal heads, bi-articular heads, and centralizers. Covers indications, contraindications, surgical warnings, sterilization, and disposal.
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Instructions for use for a group of cemented hip stems and auxiliary components including centralizers, collars, plugs, and cerclage systems. Covers indications, contraindications, surgical warnings, and post-operative care.
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Instructions for use for Beznoska cementless acetabular cups, including SF/II, TC/II, and DUO models. Covers indications, contraindications, surgical warnings, sterilization, and post-operative care.
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Instructions for use for Beznoska auxiliary items, specifically K-wires and Osteofix wires, used in total hip replacement and bone fragment fixation. Includes details on material (ISO 5832-1), sterilization, surgical handling, contraindications, and warnings.
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Instructions for use for the ELiS Total Trapezium-Metacarpal Joint Replacement, covering indications, contraindications, surgical procedure, material composition, and patient safety information.
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Instructions for use for acetabulum reconstruction cages and BS-reconstruction cages, including indications, contraindications, surgical procedure references, and warnings for hip joint replacement surgery.
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Instructions for use for the SVR and SVR II Total Knee Replacement system, covering components, assembly, surgical indications, contraindications, and post-operative care.
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A comprehensive guide defining the symbols used on medical device packaging and labeling, compliant with ISO 15223-1 and ISO 7010 standards.
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A comprehensive guide defining the symbols used on medical device packaging and labeling, compliant with ISO 15223-1 and ISO 7010 standards.
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Instruction for use for the ELiS Total Trapeziometacarpal Joint Replacement system, covering indications, contraindications, surgical procedure warnings, and material specifications for stems, necks, cups, and trapezium replacements.
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Instructions for use for the CMS Total Knee Replacement system, including femoral components, tibial plateaus, inserts, and extension stems. Covers indications, contraindications, surgical warnings, sterility information, and post-operative care.
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Instructions for use for the SVS total knee replacement system, including femoral components, tibial plateaus, inserts, and patellar replacements. Covers indications, contraindications, surgical warnings, handling, and post-operative care.
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Instructions for use for the SVL total knee replacement system, including femoral components, tibial plateaus, inserts, and patella components. Covers indications, contraindications, surgical warnings, and post-operative care.