Double Internal Joint Stabilizer- Elbow

FDA 510(k) K231447 · Skeletal Dynamics, Inc.

Substantially Equivalent

510(k) numberK231447

Submission

Device name
Double Internal Joint Stabilizer- Elbow
Applicant
Skeletal Dynamics, Inc.
Miami, FL, US
Received
May 18, 2023
Decision date
December 15, 2023
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
K223318Internal Joint Stabilizer - ElbowOZI · Traditional Skeletal Dynamics, Inc.05/10/2023SE
K153208Internal Joint Stabilizer - ElbowOZI · Traditional Skeletal Dynamics, LLC12/31/2015SE

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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
K231188ALIGN Radial Head SystemKWI · Traditional 09/28/2023SE

Questions and answers

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

Double Internal Joint Stabilizer- Elbow (K231447) received a 510(k) decision of Substantially Equivalent on December 15, 2023, 211 days after the submission was received.

What is the product code of K231447?

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