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SpineCraft
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    • Deformity >
      • ASTRA Deformity Spine System
      • ASTRA-OCT Posterior Cervical System
      • APEX Deformity Spine System
      • PSO Instrument Set
    • Revision & Extension >
      • ASTRA Revision Spine System
    • Degenerative >
      • ASTRA Degenerative Spine System
      • APEX Degenerative Spine System
      • ORIO-PL PLIF PEEK-Optima® Cage
      • ORIO-Ti PLIF Trapezoidal Titanium Cage
      • ORIO-TL Curved TLIF PEEK-Optima® Cage
      • ORIO-TL Oblique TLIF PEEK-Optima® Cage
      • ORIO-Ti TLIF Titanium Cage
    • Minimally Invasive Surgery (MIS) >
      • STAC Technique
      • PANORAMA MIS Retractor System
      • AVANT MIS System
      • AIM MIS System
    • Cervical >
      • ASTRA-OCT Posterior Cervical System
      • VELOX ACP
      • ORIO-C Cervical PEEK-Optima® Cage
      • ORIO-Ti Cervical Titanium Cage
      • ALLTUM ACP
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      • Osteopore Allo DBM
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Quality System

SpineCraft's comprehensive Quality System is designed to achieve high quality standards through strict levels of quality control. SpineCraft's achievement of quality is indicative of the importance placed on meeting patients' and customers' needs and is exemplified by the high quality products being offered.

The SpineCraft Quality Policy reflects our Company's dedication to Quality. In order to ensure the Achievement of Excellence through a comprehensive and effective Quality System, we are engaged in an ongoing focus and commitment to the following objectives:

       §      Improving human welfare through enhanced quality of life and restored health,  

       §      Achieving high quality standards through compliance with requirements and maintenance of the effectiveness of the
​               Quality Management System, and

       §      Providing total customer satisfaction, both by medical providers and patients, from design to end use. SpineCraft's Quality

Management System is in-accordance with 21 CFR Part 820 - Medical Devices, Quality System Regulation - and GMP. SpineCraft's Quality Management System also incorporates the requirements of applicable ISO Standards, as well as European Medical Device Directives. SpineCraft emphasizes a total quality assurance approach to all aspects of business.

Awareness of Quality Systems and procedures is maintained through employee training and is practiced company-wide. The SpineCraft Quality Management System provides the organizational structure to ensure that products are processed, manufactured, controlled, and distributed according to the appropriate regulatory requirements and corporate policies/procedures.

Continuous quality improvement is the basis for the Quality Management System. The periodic reviews of the system identify the strategic plans required to develop, implement, and modify the Quality Management System and identify the processes, controls, equipment, fixtures, resources, and skills necessary to meet ongoing quality requirements.

SpineCraft is a U.S. FDA-registered medical device establishment and is certified to the international quality standards (ISO 13485:2016) for the design, manufacture, and distribution of Spine Implants and Instruments as well as Orthobiologics.
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Certificates and Registrations: 
       §      US FDA Annual Registration of Device Establishment  
       §      ISO 13485: 2016

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​777 Oakmont Lane 
​Westmont, IL 60559
PH +1 630 920 7300   FX +1 630 920 7310 
TF 877 731 SPINE (877 731 7746)

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