Cleared Traditional

Internal Joint Stabilizer - Elbow

K153208 · Skeletal Dynamics, LLC · Orthopedic

Dec 2015

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K153208 is an FDA 510(k) clearance for the Internal Joint Stabilizer - Elbow, a Internal Hinged Elbow Fixator (Class II — Special Controls, product code OZI), submitted by Skeletal Dynamics, LLC (Miami, US). The FDA issued a Cleared decision on December 31, 2015, 56 days after receiving the submission on November 5, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K153208 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 2015
Decision Date	December 31, 2015
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OZI — Internal Hinged Elbow Fixator
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030
Definition	The Hinged Internal Fixator Is Intended To Treat Joint Dislocations, More Specifically Of The Elbow Joint. The Device Is Intended To Be Removed Once Stability Is Achieved.