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Cranial Surgical Planning And Instrument Guides

FDA product code PPT · 4 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.4310
Review panel
NE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-09-23 – 2026-01-07

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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