Cleared Traditional

OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR

K123885 · Osteomed LP · Neurology

Jun 2013

Decision

167d

Days

Class 2

Risk

About This 510(k) Submission

K123885 is an FDA 510(k) clearance for the OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR, a Cranial Distraction System (Class II — Special Controls, product code PBJ), submitted by Osteomed LP (Addison, US). The FDA issued a Cleared decision on June 3, 2013, 167 days after receiving the submission on December 18, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number	K123885 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 2012
Decision Date	June 03, 2013
Days to Decision	167 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.