FYI · Appliance, Facial Fracture, External
General, Plastic Surgery · 21 CFR 878.3250 · Class 1
Overview
| Product Code | FYI |
|---|---|
| Device Name | Appliance, Facial Fracture, External |
| Regulation | 21 CFR 878.3250 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
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.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K871073 | OMEGA BIVALVE NASAL SPLINTS | Omega Silicone, Inc. | May 11, 1987 | SESE |
| K821178 | ETHICON EXTERNAL FIXATION WIRE | ETHICON, Inc. | Jun 11, 1983 | SESE |
| K801072 | STRAITH NASAL SPLINT | Surgical Technology Laboratories, Inc. | Jun 17, 1980 | SESE |
| K792106 | CONPHAR O.R. HEAD COVER-STERILE | Conphar, Inc. | Nov 5, 1979 | SESE |
Top Applicants
- Conphar, Inc. — 1 clearance
- ETHICON, Inc. — 1 clearance
- Omega Silicone, Inc. — 1 clearance
- Surgical Technology Laboratories, Inc. — 1 clearance
