{"data":{"id":"us/21-cfr-882.4750","jurisdiction":"us","citation":"21 CFR 882.4750","heading":"Skull punch.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 882—NEUROLOGICAL DEVICES","Subpart E—Neurological Surgical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"8c4f6d7b412e1167c2bf1a85b0fb2ba77ed52e3a5d10d8c56f0e85f46fed5c11","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-882.4725","next":"us/21-cfr-882.4800"},"notice":"GroundRules: Original legal text. Not legal advice."}