COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Competitor Unicondylar All-poly Tibial Baseplate.

Pre-market Notification Details

• Device ID: K061779
• 510k Number: K061779
• Device Name: COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
• Classification: Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Gino Rouss
• Correspondent: Gino Rouss; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: HSX
• CFR Regulation Number: 888.3520 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-06-26
• Decision Date: 2006-08-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03596010589088	K061779	000
03596010589323	K061779	000
03596010589330	K061779	000
03596010589354	K061779	000
03596010589361	K061779	000
03596010589385	K061779	000
03596010589408	K061779	000
03596010589422	K061779	000
03596010589439	K061779	000
03596010589446	K061779	000
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03596010589538	K061779	000
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03596010589163	K061779	000
03596010593672	K061779	000