Block, Cutting, Ent, Non-Sterile
The ENT cutting block (non-sterile) is a prosthesis modification instrument used in ossicular replacement surgery as a stable platform for cutting and shaping prosthesis components. It is classified as FDA Class 1 under regulation 874.3540 in the Ear, Nose, and Throat specialty, and it is GMP exempt. Product code NNR does not require 510(k) clearance and is associated with product code JXS.
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Basic Information
- Product Code
- NNR
- Device Class
- FDA class 1
- Regulation Number
- 874.3540
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
Definition
Prosthesis modification instrument for ossicular replacement surgery; see product code JXS.
FEI Numbers
This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.