{"data":{"id":"us/21-cfr-878.3250","jurisdiction":"us","citation":"21 CFR 878.3250","heading":"External facial fracture fixation appliance.","body":"(a) Identification. An external facial fracture fixation appliance is a metal apparatus intended to be used during surgical reconstruction and repair to immobilize maxillofacial bone fragments in their proper facial relationship.\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 § 878.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 878—GENERAL AND PLASTIC SURGERY DEVICES","Subpart D—Prosthetic 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":"cdd3cc9f366ade56421f4d6bf63179b5ff9cb03a4a8a9cd18a37072b6b9d7705","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.1820","next":"us/21-cfr-878.3300"},"notice":"GroundRules: Original legal text. Not legal advice."}