KINEMAX PLUS ALL PLASTIC TIBIAL COMPONENT

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

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Kinemax Plus All Plastic Tibial Component.

Pre-market Notification Details

• Device ID: K921640
• 510k Number: K921640
• Device Name: KINEMAX PLUS ALL PLASTIC TIBIAL COMPONENT
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070
• Contact: Robert E Smith
• Correspondent: Robert E Smith; HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-04-06
• Decision Date: 1992-09-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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