36MM Cocr Femoral Head and 36MM Acetabular Insert

Q: What is the product code of K070061?

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.

FDA 510(k) K070061 · Hayes Medical, Inc.

Substantially Equivalent

510(k) numberK070061

Submission

Device name: 36MM Cocr Femoral Head and 36MM Acetabular Insert
Applicant: Hayes Medical, Inc.
El Dorado Hills, CA, US
Received: January 5, 2007
Decision date: January 31, 2007
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary 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

510(k)	Device	Applicant	Decision
K120595	Unisyn Plus Hip StemLWJ · Traditional	Consensus Orthopedics, Inc.	10/12/2012SE
K103518	Trinity Acetabular SystemLWJ · Traditional	Corin USA	03/09/2011SE
K090764	Novation CFS Press-Fit and Cemented StemsLWJ · Special	Exactech, Inc.	04/21/2009SE
K082146	Metha Short Stem Hip System XL Femoral HeadLWJ · Special	Aesculap Implant Systems, Inc.	09/09/2008SE
K062978	U2 Hip Stem, Ti Plasma SprayLWJ · Traditional	United Orthopedic Corp.	01/16/2007SE
K062383	Unisyn Ha Plasma Modular HipLWJ · Special	Hayes Medical, Inc.	12/21/2006SE
K061699	ExciaLWJ · Special	Aesculap, Inc.	08/18/2006SE
K051826	Betacone Hip Prosthesis SystemLWJ · Traditional	Waldemar Link GmbH & Co. KG	11/18/2005SE
K050262	U2 Acetabular ComponentLWJ · Traditional	United Orthopedic Corp.	08/15/2005SE
K042344	Excia Total Hip SystemLWJ · Abbreviated	Aesculap, Inc.	03/16/2005SE

More from Aesculap, Inc.

510(k)	Device	Decision
K062383	Unisyn Ha Plasma Modular HipLWJ · Special	12/21/2006SE
K060635	Consensus Acetabular Shell SystemLPH · Special	04/28/2006SE
K030151	Consensus Hip System, Unisyn Hip SystemLZO · Traditional	04/10/2003SE
K030205	Consensus Unipolar Head, CocrKWL · Traditional	04/01/2003SE
K021466	Consensus Acetabular Insert, Cross-Linked PolyethyleneLPH · Traditional	07/24/2002SE
K020153	Consensus Acetablar Shell, Ti CoatedLPH · Traditional	04/15/2002SE
K003649	Triton Hip SystemLWJ · Traditional	02/23/2001SE
K001456	Consensus Knee SystemJWH · Traditional	08/07/2000SE
K983004	Consensus Femoral Component, Porous, Cocr/TiJWH · Traditional	11/25/1998SE
K964395	Patient Specific Implant (Psi) Hip Femoral ComponentLZO · Traditional	01/27/1997SE

Questions and answers

When was 36MM Cocr Femoral Head and 36MM Acetabular Insert cleared by the FDA?

36MM Cocr Femoral Head and 36MM Acetabular Insert (K070061) received a 510(k) decision of Substantially Equivalent on January 31, 2007, 26 days after the submission was received.

What is the product code of K070061?

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.