21 C.F.R. § 882.4900

Current through October 31, 2024
Section 882.4900 - Skullplate screwdriver
(a)Identification. A skullplate screwdriver is a tool used by the surgeon to fasten cranioplasty plates or skullplates to a patient's skull by screws.
(b)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 § 882.9 .

21 C.F.R. §882.4900

44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808 , July 25, 2001