PBJ · Cranial Distraction System
Neurology · 21 CFR 882.5330 · Class 2
Overview
| Product Code | PBJ |
|---|---|
| Device Name | Cranial Distraction System |
| Regulation | 21 CFR 882.5330 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
| Life-Sustaining | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230211 | CranioXpand | KLS-Martin L.P. | Nov 21, 2023 | SESE |
| K170818 | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | Dec 7, 2017 | SESE |
| K163315 | Internal Distraction - Sterile | KLS Martin L.P. | May 5, 2017 | SESE |
| K150771 | RxG Distraction System | KLS Martin L.P. | Aug 27, 2015 | SESE |
| K123885 | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR | Osteomed LP | Jun 3, 2013 | SESE |
| K121304 | OSTEOMED CRANIAL DISTRACTION SYSTEM | Osteomed | Aug 22, 2012 | SESE |
Top Applicants
- KLS Martin L.P. — 2 clearances
- KLS-Martin L.P. — 1 clearance
- Osteomed — 1 clearance
- Osteomed LP — 1 clearance
- Synthes USA Products, LLC — 1 clearance
