Cleared Traditional

Internal Joint Stabilizer - Elbow

K223318 · Skeletal Dynamics, Inc. · Orthopedic

May 2023

Decision

194d

Days

Class 2

Risk

About This 510(k) Submission

K223318 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, Inc. (Miami, US). The FDA issued a Cleared decision on May 10, 2023, 194 days after receiving the submission on October 28, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K223318 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 2022
Decision Date	May 10, 2023
Days to Decision	194 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.