CROSSLINKED POLYETHYLENE ARTICULAR INSERTS

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 Crosslinked Polyethylene Articular Inserts.

Pre-market Notification Details

• Device ID: K071071
• 510k Number: K071071
• Device Name: CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis, TN 38116
• Contact: Rishi Sinha
• Correspondent: Rishi Sinha; SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis, TN 38116
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-04-16
• Decision Date: 2007-09-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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