FDA product code LBM
Porous Polyethylene Ossicular Replacement
Ear, Nose, Throat·Class 2·21 CFR 874.3450·Implantable
US regulatory classifications
- US Product Code (FDA)
- LBMView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 874.3450View CFR Regulation →
- Medical specialty
- Ear, Nose, Throat
Device characteristics
- GMP exempt
- No
- Implantable
- Yes
- Life-sustaining
- No
- Third party review
- Not Eligible
Search keywords
Click to search for similar devices in our global database
About this record
Porous Polyethylene Ossicular Replacement is a medical device type in the Ear, Nose, Throat specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.