GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT

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 Genesis Ii Posterior Stabilized High Flexion Articular Insert.

Pre-market Notification Details

• Device ID: K032295
• 510k Number: K032295
• Device Name: GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Jason Sells
• Correspondent: Jason Sells; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-07-25
• Decision Date: 2003-08-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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