Trauma-Fix External Fixator

FDA 510(k) K971272 · Trend Medical, Inc.

Substantially Equivalent

510(k) numberK971272

Submission

Device name
Trauma-Fix External Fixator
Applicant
Trend Medical, Inc.
Concord, CA, US
Received
April 4, 1997
Decision date
June 5, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KTW – Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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K170693Phantom Small Bone Intramedullary Nail SystemKTW · Traditional Paragon 28, Inc.06/19/2017SE
K160409AOS Anterolateral Proximal Humeral PlateKTW · Special Advanced Orthopaedic Solutions, Inc.03/15/2016SE
K122541Orthofix Contours Proimal Humeral Plate (PHP)KTW · Special Orthofix Srl09/20/2012SE
K080590Aos Proximal Humeral PlateKTW · Traditional Advanced Orthopaedic Solutions, Inc.05/06/2008SE
K080109Synthes (USA) Modular Blade Plate SystemKTW · Traditional Synthes (Usa)03/20/2008SE
K062920Orthofix Titanium Humeral Plating System LSPKTW · Traditional Orthofix Srl11/13/2006SE
K023360Leforte System Bone PlateKTW · Traditional Jeil Medical Corporation10/25/2002SE
K012645Reprocessed Ebi External Fixation DevicesKTW · Traditional Alliance Medical Corp.06/24/2002SE

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Questions and answers

When was Trauma-Fix External Fixator cleared by the FDA?

Trauma-Fix External Fixator (K971272) received a 510(k) decision of Substantially Equivalent on June 5, 1997, 62 days after the submission was received.

What is the product code of K971272?

The FDA product code is KTW – Appliance, Fixation, Nail/Blade/Plate Combination, Single Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.