21 CFR 882.4750
§ 882.4750 Skull punch.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 882.4750, § 882.4750 Skull punch, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90707
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Full text
(a) Identification. A skull punch is a device used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flaps by wire or other means.
(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 § 882.9. This exemption does not apply to powered compound cranial drills, burrs, trephines, and their accessories classified under § 882.4305.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.