Cleared Traditional

RxG Distraction System

K150771 · KLS-Martin L.P. · Neurology

Aug 2015

Decision

156d

Days

Class 2

Risk

About This 510(k) Submission

K150771 is an FDA 510(k) clearance for the RxG Distraction System, a Cranial Distraction System (Class II — Special Controls, product code PBJ), submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on August 27, 2015, 156 days after receiving the submission on March 24, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number	K150771 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 2015
Decision Date	August 27, 2015
Days to Decision	156 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	PBJ — Cranial Distraction System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5330
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.