SPINAL IMPLANT TESTS

Spinal implants are used in the spine and play an important role in various spinal disorders. Mechanical analyses are performed in our laboratory by simulating the structure of components such as spinal screws, rods, and connectors.

Our primary testing methods, which are included in our accreditation scope and verify the performance of your spinal implants, are as follows:

  • Spinal Structure Simulation: ASTM F1717
  • Fixation Components: ASTM F2193 / F1798
  • Spinal Cage Tests: ASTM F2077 / F2267
  • Artificial Disk Tests: ASTM F2346
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SAMPLE STANDARD EXPLANATION
SPINAL STRUCTURE - SCREW/ROD ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
SPINAL ROD – SCREW ASTM F2193 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
HOOK - SPINAL SCREW ASTM F1798 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
CAGE ASTM F2077 Test Methods For Intervertebral Body Fusion Devices
CAGE ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
DISK ASTM F2346 Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs

Frequently Asked Questions

We offer professional consulting services in the establishment, integration, and certification processes of international quality, environmental, and occupational health and safety management systems, primarily focusing on medical device standards (ISO 13485) and MDR processes, as well as ISO 9001, ISO 14001, and ISO 45001.

Our processes begin with a situation analysis (GAP) where we examine your company's current structure. This is followed by an end-to-end process that includes establishing a company-specific documentation structure, integrating processes, conducting internal audits, and preparing for certification audits.

The length of the process varies depending on the scope of the chosen standard, the company's existing infrastructure, the number of employees, and the complexity of the processes. Generally, the preparation and audit processes are completed within 2 to 4 months.

Yes, we are also here to support you in ensuring the continuity of the system after certification, providing internal audit support, and preparing for annual surveillance audits.

We adhere to professional confidentiality principles in all our operations. Your company's technical and commercial information is protected under mutually signed confidentiality agreements.

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For details about our management systems processes and corporate consulting services, please contact us.

+90 (216) 376 66 21

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