Internal Joint Stabilizer - Elbow

FDA 510(k) K153208 · Skeletal Dynamics, LLC

Substantially Equivalent

510(k) numberK153208

Submission

Device name
Internal Joint Stabilizer - Elbow
Applicant
Skeletal Dynamics, LLC
Miami, FL, US
Received
November 5, 2015
Decision date
December 31, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OZI – Internal Hinged Elbow Fixator
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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.

Other 510(k)s with product code OZI

510(k)DeviceApplicantDecision
K231447Double Internal Joint Stabilizer- ElbowOZI · Traditional Skeletal Dynamics, Inc.12/15/2023SE
K223318Internal Joint Stabilizer - ElbowOZI · Traditional Skeletal Dynamics, Inc.05/10/2023SE

More from Skeletal Dynamics, Inc.

510(k)DeviceDecision
K261770Suture Button Repair SystemMBI · Traditional 07/29/2026SE
K254288Clavicle Fixation SystemHRS · Abbreviated 03/23/2026SE
K252949Geminus Volar Distal Radius Plating SystemHRS · Traditional 11/13/2025SE
K242436Proximal Humerus Fixation SystemHRS · Traditional 11/14/2024SE
K243381Total Wrist Arthroplasty System (TWA)JWJ · Special 11/01/2024SE
K241815Protean Fragment Plating SystemHRS · Traditional 09/26/2024SE
K242055Freefix Forearm Plating SystemHRS · Special 08/01/2024SE
K240835Suture Button Repair SystemMBI · Traditional 07/19/2024SE
K233574Total Wrist Arthroplasty System (TWA)JWJ · Traditional 07/03/2024SE
K231447Double Internal Joint Stabilizer- ElbowOZI · Traditional 12/15/2023SE

Questions and answers

When was Internal Joint Stabilizer - Elbow cleared by the FDA?

Internal Joint Stabilizer - Elbow (K153208) received a 510(k) decision of Substantially Equivalent on December 31, 2015, 56 days after the submission was received.

What is the product code of K153208?

The FDA product code is OZI – Internal Hinged Elbow Fixator, a Class II (moderate risk) device regulated under 21 CFR 888.3030.