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Rigid Cervical-Thoracic Orthosis Suppliers

  61 to 62 of 62 suppliers  Page: << Previous 20 Results 1 2 3 [4]
Innovative Choices, Inc. | Address: 700 Progress Ave, Scarborough, Ontario M1H 2Z7, Canada Canada
Phone: +1-(315)-482-2583
Products: Rigid Cervical-Thoracic Orthosis (FDA Code: IQF), ...
Innovative Choices, Inc. offers cervical pillows. more...
 
Spronken Orthopedie NV | Address: Grotestraat 46, Genk 3600, Belgium
Phone: +32-(32)-893-57245
Products: Rigid Cervical-Thoracic Orthosis (FDA Code: IQF), Limb & Truncal Orthosis (FDA Code: MRI), ...
Spronken Orthopedie NV offers orthopedic products. more...
  61 to 62 of 62 Rigid Cervical-Thoracic Orthosis suppliers  Page: << Previous 20 Results 1 2 3 [4]
FDA Code / Regulation: IQF / 890.3490

A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.

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