Bipolar Shoulder PROSTHESIS-SHELL(RD-113130/33, Biangular Modular HEAD(RD-113101/41/42,BIOMODULAR Modular HEAD(RD-113143

Q: What is the product code of K960363?

The FDA product code is MJT – Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented, a Class III (high risk) device.

FDA 510(k) K960363 · Biomet, Inc.

Substantially Equivalent

510(k) numberK960363

Submission

Device name: Bipolar Shoulder PROSTHESIS-SHELL(RD-113130/33, Biangular Modular HEAD(RD-113101/41/42,BIOMODULAR Modular HEAD(RD-113143
Applicant: Biomet, Inc.
Warsaw, IN, US
Received: January 25, 1996
Decision date: February 18, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MJT – Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
Device class: Class III (high risk)
Implant: Yes

Other 510(k)s with product code MJT

510(k)	Device	Applicant	Decision
K990712	Osteonics Solar Shoulder Bipolar SystemMJT · Traditional	Howmedica Osteonics Corp.	07/20/1999SE
K982418	Buechel-Pappas Modular Salvage StemMJT · Abbreviated	Endotec, Inc.	04/29/1999SE

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Questions and answers

When was Bipolar Shoulder PROSTHESIS-SHELL(RD-113130/33, Biangular Modular HEAD(RD-113101/41/42,BIOMODULAR Modular HEAD(RD-113143 cleared by the FDA?

Bipolar Shoulder PROSTHESIS-SHELL(RD-113130/33, Biangular Modular HEAD(RD-113101/41/42,BIOMODULAR Modular HEAD(RD-113143 (K960363) received a 510(k) decision of Substantially Equivalent on February 18, 1997, 390 days after the submission was received.

What is the product code of K960363?

The FDA product code is MJT – Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented, a Class III (high risk) device.