Cranial Surgical Planning And Instrument Guides

PPT · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4310

Classification

FDA Product Code: PPT
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.4310
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 9

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown