Oscar, Model OE3000DB

Q: What is the product code of K051053?

The FDA product code is JDX – Instrument, Surgical, Sonic And Accessory/Attachment, a Class II (moderate risk) device regulated under 21 CFR 888.4580.

FDA 510(k) K051053 · Orthosonics, Ltd.

Substantially Equivalent

510(k) numberK051053

Submission

Device name: Oscar, Model OE3000DB
Applicant: Orthosonics, Ltd.
Brookeville, MD, US
Received: April 25, 2005
Decision date: July 21, 2005
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JDX – Instrument, Surgical, Sonic And Accessory/Attachment
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.4580
Specialty: Orthopedic

Other 510(k)s with product code JDX

510(k)	Device	Applicant	Decision
K201274	Ultrasonic Osteotomy Surgical SystemJDX · Traditional	Smtp Technology Co., Ltd.	02/19/2021SE
K172464	XD880A Ultrasonic Osteotomy Surgical SystemJDX · Traditional	Morley Research Consortium	04/24/2018SE
K163610	PIEZOTOME M+, PIEZOTOME M+ HandpieceJDX · Traditional	Satalec-Acteon Group	05/19/2017SE
K153743	Piezosurgery PlusJDX · Traditional	Mectron S.P.A.	05/25/2016SE
K132848	Piezosurgery FlexJDX · Traditional	Mectron S.P.A.	11/29/2013SE
K100410	Piezoelectric SystemJDX · Traditional	Satelec	04/28/2010SE
K093805	Oscar 3JDX · Traditional	Orthosonics, Ltd.	02/19/2010SE
K083284	Piezosurgery MedicalJDX · Traditional	Piezosurgery S.R.L.	04/08/2009SE
K083830	Oscar Bone ResectorJDX · Traditional	Orthosonics, Ltd.	03/20/2009SE
K072961	Lotus Ultrasonic System for Cemented Implant Extraction (Uscix)JDX · Traditional	Sra Developments, Ltd.	12/19/2007SE

More from Sra Developments, Ltd.

510(k)	Device	Decision
K093805	Oscar 3JDX · Traditional	02/19/2010SE
K083830	Oscar Bone ResectorJDX · Traditional	03/20/2009SE
K021502	Oscar, Model OE3000LZV · Special	06/06/2002SE

Questions and answers

When was Oscar, Model OE3000DB cleared by the FDA?

Oscar, Model OE3000DB (K051053) received a 510(k) decision of Substantially Equivalent on July 21, 2005, 87 days after the submission was received.

What is the product code of K051053?

The FDA product code is JDX – Instrument, Surgical, Sonic And Accessory/Attachment, a Class II (moderate risk) device regulated under 21 CFR 888.4580.