DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Duracon Symmetric Metal-backed Patellar Component.

Pre-market Notification Details

• Device ID: K000091
• 510k Number: K000091
• Device Name: DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Contact: Terry Sheridan Powell
• Correspondent: Terry Sheridan Powell; HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-01-13
• Decision Date: 2000-03-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04546540318398	K000091	000