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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
510(k) Number K924724
Device Name KINETIK GREAT TOE SYSTEM
Applicant
Kinetikos Medical, Inc.
3950 Sorrento Valley Blvd.,
San Diego,  CA  92121
Applicant Contact GLYNNIS STONE
Correspondent
Kinetikos Medical, Inc.
3950 Sorrento Valley Blvd.,
San Diego,  CA  92121
Correspondent Contact GLYNNIS STONE
Classification Product Code
LZJ  
Date Received09/21/1992
Decision Date 01/05/1994
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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