Visionaire Disposable Instruments

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

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Visionaire Disposable Instruments.

Pre-market Notification Details

• Device ID: K143226
• 510k Number: K143226
• Device Name: Visionaire Disposable Instruments
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: SMITH & NEPHEW, INC. 7135 GOODLETT FARMS PARKWAY Cordova, TN 38016
• Contact: Shereen Bienz
• Correspondent: Shereen Bienz; SMITH & NEPHEW, INC. 7135 GOODLETT FARMS PARKWAY Cordova, TN 38016
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-11-10
• Decision Date: 2015-02-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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