21 CFR § 878.3250 General and Plastic Surgery Devices

§ 878.3250 External facial fracture fixation appliance.

Current through Sep 8, 2026 · Read all of Part 878

⚠ 2 pending changes to Part 878

(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.

(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.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000]

← § 878.1820 Software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer.§ 878.3300 Surgical mesh. →