21 CFR 878.3250 — Appliance, Facial Fracture, External

General, Plastic Surgery (SU) · Part 878 Subpart D—Prosthetic Devices · § 878.3250

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.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
FYIAppliance, Facial Fracture, External14
Innolitics

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