NDL · Pin, Fixation, Smooth, Metallic
Orthopedic · 21 CFR 888.3040 · Class 2
Overview
| Product Code | NDL |
|---|---|
| Device Name | Pin, Fixation, Smooth, Metallic |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K010847 | K'FIX | Avanta Orthopaedics, Inc. | Jun 19, 2001 | SESE |
| K010545 | TBW | Tri-Med, Inc. | Jun 6, 2001 | SESE |
Top Applicants
- Tri-Med, Inc. — 1 clearance
- Avanta Orthopaedics, Inc. — 1 clearance
