{"data":{"id":"us/21-cfr-882.5330","jurisdiction":"us","citation":"21 CFR 882.5330","heading":"Preformed nonalterable cranioplasty plate.","body":"(a) Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.\n(b) Classification. Class II (performance standards).","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 F—Neurological Therapeutic 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":"9d9562c5493aef4c6763eea14966021e1e22764f08ad92e365f5a9952f19fd9f","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-882.5320","next":"us/21-cfr-882.5360"},"notice":"GroundRules: Original legal text. Not legal advice."}