ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM
Device Facts
| Record ID | K944092 |
|---|---|
| Device Name | ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM |
| Applicant | Orthofix Srl |
| Product Code | JEC · Orthopedic |
| Decision Date | Apr 4, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
