Chrome Cobalt Ball Head

FDA 510(k) K962268 · Artos Medical Products GmbH

Substantially Equivalent

510(k) numberK962268

Submission

Device name
Chrome Cobalt Ball Head
Applicant
Artos Medical Products GmbH
Indianapolis, IN, US
Received
June 13, 1996
Decision date
October 23, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3360
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code LWJ

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K120595Unisyn Plus Hip StemLWJ · Traditional Consensus Orthopedics, Inc.10/12/2012SE
K103518Trinity Acetabular SystemLWJ · Traditional Corin USA03/09/2011SE
K090764Novation CFS Press-Fit and Cemented StemsLWJ · Special Exactech, Inc.04/21/2009SE
K082146Metha Short Stem Hip System XL Femoral HeadLWJ · Special Aesculap Implant Systems, Inc.09/09/2008SE
K07006136MM Cocr Femoral Head and 36MM Acetabular InsertLWJ · Special Hayes Medical, Inc.01/31/2007SE
K062978U2 Hip Stem, Ti Plasma SprayLWJ · Traditional United Orthopedic Corp.01/16/2007SE
K062383Unisyn Ha Plasma Modular HipLWJ · Special Hayes Medical, Inc.12/21/2006SE
K061699ExciaLWJ · Special Aesculap, Inc.08/18/2006SE
K051826Betacone Hip Prosthesis SystemLWJ · Traditional Waldemar Link GmbH & Co. KG11/18/2005SE
K050262U2 Acetabular ComponentLWJ · Traditional United Orthopedic Corp.08/15/2005SE

More from United Orthopedic Corp.

510(k)DeviceDecision
K962034SC, Cementless Hip SystemLWJ · Traditional 10/23/1996SE
K962086CPS, Cemented Cup SystemJDI · Traditional 08/07/1996SE
K961899CPS, Cemented Hip SystemJDI · Traditional 08/01/1996SE

Questions and answers

When was Chrome Cobalt Ball Head cleared by the FDA?

Chrome Cobalt Ball Head (K962268) received a 510(k) decision of Substantially Equivalent on October 23, 1996, 132 days after the submission was received.

What is the product code of K962268?

The FDA product code is LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3360.