Appliance, Facial Fracture, External
An external facial fracture appliance is an orthopedic device applied externally to support and immobilize facial bones following fracture or reconstructive surgery, providing stability during healing. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FYI, regulated under 21 CFR 878.3250, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- FYI
- Device Class
- FDA class 1
- Regulation Number
- 878.3250
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K871073 | OMEGA BIVALVE NASAL SPLINTS | May 11, 1987 | Substantially Equivalent | Omega Silicone, Inc. |
| K821178 | ETHICON EXTERNAL FIXATION WIRE | Jun 11, 1983 | Substantially Equivalent | ETHICON, Inc. |
| K801072 | STRAITH NASAL SPLINT | Jun 17, 1980 | Substantially Equivalent | Surgical Technology Laboratories, Inc. |
| K792106 | CONPHAR O.R. HEAD COVER-STERILE | Nov 05, 1979 | Substantially Equivalent | Conphar, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.