Reprocessed External Fixation Device

Q: What is the product code of K012634?

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.

FDA 510(k) K012634 · Alliance Medical, Inc.

Substantially Equivalent

510(k) numberK012634

Submission

Device name: Reprocessed External Fixation Device
Applicant: Alliance Medical, Inc.
Phoenix, AZ, US
Received: August 13, 2001
Decision date: June 24, 2002
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

Other 510(k)s with product code KTW

510(k)	Device	Applicant	Decision
K182285	PK High Tibial Osteotomy Correction SystemKTW · Traditional	Paonan Biotech Co., Ltd.	06/20/2019SE
K171606	AOS Anterolateral Proximal Humeral PlateKTW · Special	Advanced Orthopaedic Solutions, Inc. (Aos)	06/22/2017SE
K170693	Phantom Small Bone Intramedullary Nail SystemKTW · Traditional	Paragon 28, Inc.	06/19/2017SE
K160409	AOS Anterolateral Proximal Humeral PlateKTW · Special	Advanced Orthopaedic Solutions, Inc.	03/15/2016SE
K122541	Orthofix Contours Proimal Humeral Plate (PHP)KTW · Special	Orthofix Srl	09/20/2012SE
K080590	Aos Proximal Humeral PlateKTW · Traditional	Advanced Orthopaedic Solutions, Inc.	05/06/2008SE
K080109	Synthes (USA) Modular Blade Plate SystemKTW · Traditional	Synthes (Usa)	03/20/2008SE
K062920	Orthofix Titanium Humeral Plating System LSPKTW · Traditional	Orthofix Srl	11/13/2006SE
K023360	Leforte System Bone PlateKTW · Traditional	Jeil Medical Corporation	10/25/2002SE
K012645	Reprocessed Ebi External Fixation DevicesKTW · Traditional	Alliance Medical Corp.	06/24/2002SE

More from Alliance Medical Corp.

510(k)	Device	Decision
K060648	Reprocessed Phacoemulsification TipsNKX · Traditional	03/19/2007SE
K061045	Reprocessed Electrophysiology CathetersNLH · Traditional	08/31/2006SE
K051438	Vanguard Reprocessed Compression Garments (Hill-Rom)JOW · Traditional	04/04/2006SE
K060049	Reprocessed Compression SleevesJOW · Traditional	02/24/2006SE
K060091	Alliance Medical Corporation Reprocessed Compression SleevesJOW · Traditional	02/17/2006SE
K053316	Reprocessed Compression SleevesJOW · Traditional	02/13/2006SE
K052918	Reprocessed External Fixation DevicesKTT · Traditional	01/27/2006SE
K052603	Reprocessed Daig Livewire Electrophysiology CathetersNLH · Traditional	11/16/2005SE
K052414	Reprocessed Electrophysiology CatheterNLH · Traditional	11/16/2005SE
K050518	Reprocessed Phacoemuisification TipsNKX · Traditional	09/23/2005SE

Questions and answers

When was Reprocessed External Fixation Device cleared by the FDA?

Reprocessed External Fixation Device (K012634) received a 510(k) decision of Substantially Equivalent on June 24, 2002, 315 days after the submission was received.

What is the product code of K012634?

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.