Last synced on 27 January 2023 at 11:04 pm

Cranial Distraction System

Page Type
Product Code
Definition
A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull. The bone segments are attached to the plate with screws to prevent movement of the segments.
Physical State
May include: distractors, distraction plates, spacers, screws and instrumentation
Technical Method
Bone segments are attached to the plate with screws to prevent movement of the segments.
Target Area
Cranium, skull
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5330
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 882.5330 Preformed nonalterable cranioplasty plate

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a) Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

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

Cranial Distraction System

Page Type
Product Code
Definition
A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull. The bone segments are attached to the plate with screws to prevent movement of the segments.
Physical State
May include: distractors, distraction plates, spacers, screws and instrumentation
Technical Method
Bone segments are attached to the plate with screws to prevent movement of the segments.
Target Area
Cranium, skull
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5330
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 882.5330 Preformed nonalterable cranioplasty plate

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a) Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

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