Saw, Manual And Accessories
The Saw, Manual And Accessories (product code GDR) is a hand-operated surgical saw along with its associated accessories, used to cut bone during general or plastic surgery procedures such as amputations, osteotomies, or reconstructive operations. It is classified as FDA Class 1, the lowest risk level, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- GDR
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- 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 84 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 84 registration numbers. Click on an entry to view related FDA registrations.