NDK · System, External Fixator (With Metallic Invasive Components)
Orthopedic · 21 CFR 888.3040 · Class 2
Overview
| Product Code | NDK |
|---|---|
| Device Name | System, External Fixator (With Metallic Invasive Components) |
| 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K140649 | VECTRIX EXTERNAL FIXATOR | 3D Medical Concepts, LLC | Dec 29, 2014 | SESE |
| K122208 | EXTERNAL FIXATOR SYSTEM | Christopher D. Endara | Dec 20, 2012 | SESE |
| K101375 | TRIMED X-FIX | TriMed, Inc. | Sep 15, 2010 | SESE |
Top Applicants
- TriMed, Inc. — 1 clearance
- Christopher D. Endara — 1 clearance
- 3D Medical Concepts, LLC — 1 clearance
