Pin, Fixation, Threaded, Metallic
The Pin, Fixation, Threaded, Metallic (product code NDM) is a threaded metallic orthopedic pin that provides anchoring and fixation of bone fragments through thread engagement, used in fracture fixation or external fixator systems. 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. As an implanted metallic component, it carries an implant flag and is not designated as life-sustaining or GMP-exempt.
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Basic Information
- Product Code
- NDM
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K100707 | REPROCESSED PINS | Jun 25, 2010 | Substantially Equivalent | Sterilmed, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.