Cranial Distraction System
The Cranial Distraction System is a metal implantable device used to establish osteodistraction and bone growth in the skull; bone segments are attached to plates with screws to prevent movement during the distraction process. It falls under the Neurology medical specialty and is classified as a Class 2 device under regulation 882.5330, requiring 510(k) premarket notification. The device is both an implant and life-sustaining, reflecting its role in promoting cranial bone growth in patients with skull abnormalities. General controls and special controls apply.
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Basic Information
- Product Code
- PBJ
- Device Class
- FDA class 2
- Regulation Number
- 882.5330
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K230211 | CranioXpand | Nov 21, 2023 | Substantially Equivalent | KLS-Martin L.P. |
| K170818 | Craniomaxillofacial Distraction System (CMFD) | Dec 07, 2017 | Substantially Equivalent | Synthes USA Products, LLC |
| K163315 | Internal Distraction - Sterile | May 05, 2017 | Substantially Equivalent | KLS Martin L.P. |
| K150771 | RxG Distraction System | Aug 27, 2015 | Substantially Equivalent | KLS Martin L.P. |
| K123885 | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR | Jun 03, 2013 | Substantially Equivalent | Osteomed LP |
| K121304 | OSTEOMED CRANIAL DISTRACTION SYSTEM | Aug 22, 2012 | Substantially Equivalent | Osteomed |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.