PBJ — Cranial Distraction System Class II
FDA product code PBJ covers "Cranial Distraction System", a Class II medical device regulated under 21 CFR 882.5330. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PBJ
- Device Class
- Class II
- Regulation Number
- 882.5330
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K230211 | kls-martin l.p | CranioXpand | November 21, 2023 |
| K170818 | synthes usa products | Craniomaxillofacial Distraction System (CMFD) | December 7, 2017 |
| K163315 | kls martin l.p | Internal Distraction - Sterile | May 5, 2017 |
| K150771 | kls martin l.p | RxG Distraction System | August 27, 2015 |
| K123885 | osteomed | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR | June 3, 2013 |
| K121304 | osteomed | OSTEOMED CRANIAL DISTRACTION SYSTEM | August 22, 2012 |