{"data":{"id":"us/21-cfr-882.4500","jurisdiction":"us","citation":"21 CFR 882.4500","heading":"Cranioplasty material forming instrument.","body":"(a) Identification. A cranioplasty material forming instrument is a roller used in the preparation and forming of cranioplasty (skull repair) materials.\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 the limitations in § 882.9.","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":"cf1fc82a521d70619c81414681765f6dcc520e0dac4057270c366760ed2590ce","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-882.4460","next":"us/21-cfr-882.4525"},"notice":"GroundRules: Original legal text. Not legal advice."}