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Hi,
Can anyone tell me where the line is drawn between neurologic and orthopedic when it comes to spinal devices. 882.4535 (Nonpowered neurosurgical instruments) are hand held instruments or accessories to a hand instrument used during neurosurgical procedures, while 888.4540 identifies similar instrumentation for orthopedic surgical use.
If 21 CFR 882 is specific to the brain or nervous system, and 21 CFR 888 is specific to orthopedic (bone and soft tissue), can I assume that something is cleared for use in the spine (bone) if it has been cleared for orthopedic use?
Thanks.