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 | | The complications associated with pedicle screw spinal systems during this period were comparable to those reported in the preamble to the proposed rule for pedicle screw spinal systems and the group of class II spinal devices using hooks and/or wires and noninstrumented fusions. |
 | | Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allows the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. |
 | | Pedicle screw spinal systems for all other uses are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni- 5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow [[Page 40041]] the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. |
| www.fda.gov /ohrms/dockets/98fr/072798b.txt (13938 words) |
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