UNIVERSAL TOTAL WRIST SYSTEM

Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained

KINETIKOS MEDICAL, INC.

The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Universal Total Wrist System.

Pre-market Notification Details

Device IDK030037
510k NumberK030037
Device Name:UNIVERSAL TOTAL WRIST SYSTEM
ClassificationProsthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
Applicant KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD, STE 180 Carlsbad,  CA  92011
ContactJohn Spampinato
CorrespondentJohn Spampinato
KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD, STE 180 Carlsbad,  CA  92011
Product CodeJWJ  
CFR Regulation Number888.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-06
Decision Date2003-02-05
Summary:summary

NIH GUDID Devices

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