GENESIS UNICOMPARTMENTAL KNEE SYSTEM

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

SMITH & NEPHEW RICHARDS, INC.

The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Genesis Unicompartmental Knee System.

Pre-market Notification Details

• Device ID: K912735
• 510k Number: K912735
• Device Name: GENESIS UNICOMPARTMENTAL KNEE SYSTEM
• Classification: Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
• Applicant: SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Robert F Games
• Correspondent: Robert F Games; SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: HSX
• CFR Regulation Number: 888.3520 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-06-20
• Decision Date: 1991-12-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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