FDA product code OSF
Patient Specific Manual Orthopedic Stereotaxic System
Neurology·Class 2·21 CFR 882.4560
US regulatory classifications
- US Product Code (FDA)
- OSFView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 882.4560View CFR Regulation →
- Medical specialty
- Neurology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.
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About this record
Patient Specific Manual Orthopedic Stereotaxic System is a medical device type in the Neurology 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.
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.