DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

DEPUY (IRELAND)

The following data is part of a premarket notification filed by Depuy (ireland) with the FDA for Depuy Attune Knee System - Cementless Cr And Ps Femoral Componenets.

Pre-market Notification Details

• Device ID: K140881
• 510k Number: K140881
• Device Name: DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS
• Classification: Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
• Applicant: DEPUY (IRELAND) LOUGHBEG RINGASKIDDY Co. Cork, IE
• Contact: Nancy Friddle
• Correspondent: Nancy Friddle; DEPUY (IRELAND) 700 Orthopaedic Drive Warsaw, IN 46581
• Product Code: MBH
• CFR Regulation Number: 888.3565 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-04-07
• Decision Date: 2015-02-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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