Driver, Surgical, Pin
The Driver, Surgical, Pin (product code GFC) is a powered or manual instrument attachment used to drive pins or fixation hardware during general and plastic surgery procedures. It is classified as an FDA Class 1 device, representing the lowest risk tier, subject to general controls and not requiring premarket notification. Regulated under 21 CFR 878.4820 in the General, Plastic Surgery specialty (SU), this device has no special flags for implantation, life support, GMP exemption, or third-party review.
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Basic Information
- Product Code
- GFC
- Device Class
- FDA class 1
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
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 86 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 86 registration numbers. Click on an entry to view related FDA registrations.