M2A-MAGNUM Tri-Spike Acetabular Component

Q: What is the product code of K062995?

The FDA product code is KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), a Class III (high risk) device regulated under 21 CFR 888.3330.

FDA 510(k) K062995 · Biomet Manufacturing Corp

Substantially Equivalent

510(k) numberK062995

Submission

Device name: M2A-MAGNUM Tri-Spike Acetabular Component
Applicant: Biomet Manufacturing Corp
Warsaw, IN, US
Received: October 2, 2006
Decision date: October 31, 2006
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device class: Class III (high risk)
Regulation: 21 CFR 888.3330
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code KWA

510(k)	Device	Applicant	Decision
K122778	Profemur Z Revision Hip StemKWA · Special	Wrightmedicaltechnologyinc	10/11/2012SE
K121544	Dynasty Biofoam ShellKWA · Traditional	Wrightmedicaltechnologyinc	07/30/2012SE
K113271	Metal-On-Metal Hip Systems-Additional ContraindicationsKWA · Traditional	Biomet Manufacturing, Inc.	05/18/2012SE
K113322	Conserve Thin ShellKWA · Special	Wrightmedicaltechnologyinc	02/03/2012SE
K112080	Preserve Hip StemKWA · Special	Wrightmedicaltechnologyinc	12/28/2011SE
K112150	Profemur Gladiator Ha Hip StemKWA · Traditional	Wrightmedicaltechnologyinc	11/23/2011SE
K113019	Profemur XM Wingless Distal Centralizer, Perfecta Distal CentralizerKWA · Special	Wrightmedicaltechnologyinc	11/10/2011SE
K111910	Gladiator Hip StemKWA · Traditional	Wrightmedicaltechnologyinc	10/14/2011SE
K110836	CLS Brevius Stem with Kinectiv TechnologyKWA · Traditional	Zimmer GmbH	10/07/2011SE
K110400	Taperloc Complete Microplasty StemKWA · Traditional	Biomet Manufacturing Corp	09/30/2011SE

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Questions and answers

When was M2A-MAGNUM Tri-Spike Acetabular Component cleared by the FDA?

M2A-MAGNUM Tri-Spike Acetabular Component (K062995) received a 510(k) decision of Substantially Equivalent on October 31, 2006, 29 days after the submission was received.

What is the product code of K062995?

The FDA product code is KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), a Class III (high risk) device regulated under 21 CFR 888.3330.