{"data":{"id":"us/21-cfr-882.5320","jurisdiction":"us","citation":"21 CFR 882.5320","heading":"Preformed alterable cranioplasty plate.","body":"(a) Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can 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":"9be1b2b6cc1d50099866e85a8e68aed9f1204de4a54f25c9c4238f69731eaa34","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-882.5300","next":"us/21-cfr-882.5330"},"notice":"GroundRules: Original legal text. Not legal advice."}