Silony Medical

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Instructions for Use for Implants for Posterior Spinal Fixation

12 Pages

Instructions for Use of Implants - EN  Instructions for Use (D30008) for Implants for Posterior Spinal Fixation  Important Information - Please Read Before Use!  Table of Contents 1  Product description ... 2  1.1  Sterile Implants ... 2  1.2  Non-sterile Implants ... 2  2  General Information and Warnings ... 2  3  Indications ... 5  4  Contraindications ... 6  4.1  Absolute Contraindications... 6  4.2  Relative contraindications ... 6  5  Possible Negative Consequences ... 6  6  Cleaning/Disinfection and Sterilization ... 7  6.1  Cleaning/Disinfection ... 8  6.2  Sterilization ... 9  6.3  Directions for Recleaning and Resterilization: ... 9  7  Handling and Storage ... 10  8  Reporting of incidents ... 10  9  Labelling and symbols ... 10  These instructions for use apply to all spinal implants of the available VERTICALE systems. Other manufacturer’s instructions are available that contain information that is required for application of the system. The additional information, such as instrumentation guides, inserts containing useful information, and other product-specific information, may be viewed under the following two links: -  https://elabeling.silony-medical.com www.silony-medical.com  Instructions for use D30003 may be used as reference for reprocessing instruments. Instructions for use D30011 are for sterile instruments. Any manufacturer liability is excluded in the event of non-compliance with the manufacturer’s information.  D30008.i.EN – 02.03.2022 Silony Medical VERTICALE Implants - replaces all previous editions  Page 1 of 12
File Type: PDF
File Size: 645 KB
File Name: Silony Medical - Verticale - D30008 - Instructions for Use for Implants for Posterior Spinal Fixation - 2022-03.pdf

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