System, External Fixator (With Metallic Invasive Components)
The System, External Fixator (With Metallic Invasive Components) (product code NDK) is an orthopedic device used to stabilize bone fractures or correct deformities by applying an external frame attached to the bone via metallic pins or wires that penetrate the skin. It is an FDA Class 2 device within the Orthopedic specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The invasive metallic components qualify it as an implant, and it is not flagged as life-sustaining or GMP-exempt.
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Basic Information
- Product Code
- NDK
- Device Class
- FDA class 2
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140649 | VECTRIX EXTERNAL FIXATOR | Dec 29, 2014 | Substantially Equivalent | 3D Medical Concepts, LLC |
| K122208 | EXTERNAL FIXATOR SYSTEM | Dec 20, 2012 | Substantially Equivalent | Christopher D. Endara |
| K101375 | TRIMED X-FIX | Sep 15, 2010 | Substantially Equivalent | TriMed, 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.