GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)

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

RICHARDS MEDICAL CO., INC.

The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Gustilo/rand Total Knee System (genesis).

Pre-market Notification Details

• Device ID: K871146
• 510k Number: K871146
• Device Name: GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Robert F Games
• Correspondent: Robert F Games; RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-03-23
• Decision Date: 1987-07-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556915219	K871146	000
03596010184559	K871146	000
03596010184566	K871146	000
03596010450234	K871146	000
03596010450890	K871146	000
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03596010184283	K871146	000
03596010184290	K871146	000
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03596010184313	K871146	000
03596010184498	K871146	000
03596010184450	K871146	000
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00885556914076	K871146	000
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03596010184054	K871146	000
03596010184078	K871146	000
03596010184085	K871146	000
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03596010184368	K871146	000
03596010184382	K871146	000
03596010184412	K871146	000
03596010184320	K871146	000
03596010184337	K871146	000
03596010450135	K871146	000
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03596010450203	K871146	000
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03596010450395	K871146	000
03596010450807	K871146	000
03596010450845	K871146	000
03596010450920	K871146	000
03596010451033	K871146	000
03596010451064	K871146	000
03596010184542	K871146	000
03596010184535	K871146	000
03596010184528	K871146	000
03596010184344	K871146	000
03596010184351	K871146	000
03596010184375	K871146	000
03596010184399	K871146	000
03596010184405	K871146	000
03596010184436	K871146	000
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03596010184481	K871146	000
03596010184504	K871146	000
03596010184511	K871146	000
03596010451095	K871146	000