Pin, Fixation, Smooth, Metallic
The Pin, Fixation, Smooth, Metallic (product code NDL) is a smooth metallic orthopedic pin used to temporarily or permanently stabilize bone fragments, commonly in small bone or pediatric fracture fixation. 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 device is implanted in the body and carries an implant designation, and it is not flagged as life-sustaining or GMP-exempt.
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Basic Information
- Product Code
- NDL
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.