K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)

Prosthesis, Toe, Hemi-, Phalangeal

KINETIKOS MEDICAL, INC.

The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for K2 Hemi Toe Implant System (formerly Zobel Great Toe Implant System).

Pre-market Notification Details

Device IDK023770
510k NumberK023770
Device Name:K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
ClassificationProsthesis, Toe, Hemi-, Phalangeal
Applicant KINETIKOS MEDICAL, INC. 4115 SORRENTO VALLEY BLVD. San Diego,  CA  92121
ContactJohn Spampinato
CorrespondentJohn Spampinato
KINETIKOS MEDICAL, INC. 4115 SORRENTO VALLEY BLVD. San Diego,  CA  92121
Product CodeKWD  
CFR Regulation Number888.3730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-12
Decision Date2002-12-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M248201040KMI1 K023770 000
M2482010301 K023770 000
M2482010201 K023770 000
M2482010101 K023770 000
M248HEMISET1 K023770 000
M24820310041 K023770 000

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