Last synced on 23 September 2022 at 11:05 pm

Cranial Surgical Planning And Instrument Guides

Page Type
Product Code
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.
Physical State
Software and hardware
Technical Method
Pre-surgical planning including transferring, visualizing, and editing medical data. Patient-specific templates/guides are based on a pre-operative plan and are designed to fit a specific patient. These templates/guides are used to assist a surgeon in guiding the marking of bone and/or guiding surgical instruments.
Target Area
Cranial bone
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4310
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories

§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.

(a) Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

(b) Classification. Class II (performance standards).

Cranial Surgical Planning And Instrument Guides

Page Type
Product Code
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.
Physical State
Software and hardware
Technical Method
Pre-surgical planning including transferring, visualizing, and editing medical data. Patient-specific templates/guides are based on a pre-operative plan and are designed to fit a specific patient. These templates/guides are used to assist a surgeon in guiding the marking of bone and/or guiding surgical instruments.
Target Area
Cranial bone
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4310
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories

§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.

(a) Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

(b) Classification. Class II (performance standards).