FDA product code PPT

Cranial Surgical Planning And Instrument Guides

Neurology·Class 2·21 CFR 882.4310
US regulatory classifications
US Product Code (FDA)
PPT
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.4310
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures.

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About this record

Cranial Surgical Planning And Instrument Guides 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.