Cleared Traditional

OSTEOMED CRANIAL DISTRACTION SYSTEM

K121304 · Osteomed · Neurology

Aug 2012

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K121304 is an FDA 510(k) clearance for the OSTEOMED CRANIAL DISTRACTION SYSTEM, a Cranial Distraction System (Class II — Special Controls, product code PBJ), submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on August 22, 2012, 113 days after receiving the submission on May 1, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number	K121304 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2012
Decision Date	August 22, 2012
Days to Decision	113 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.