LEFORTE NEUROSYSTEM BONE SCREW

Screw, Fixation, Bone

JEIL MEDICAL CORPORATION

The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Leforte Neurosystem Bone Screw.

Pre-market Notification Details

Device IDK091686
510k NumberK091686
Device Name:LEFORTE NEUROSYSTEM BONE SCREW
ClassificationScrew, Fixation, Bone
Applicant JEIL MEDICAL CORPORATION 215 S. STATE STREET STE: 100B Salt Lake City,  UT  84111
ContactShin Kuk Yoo
CorrespondentShin Kuk Yoo
JEIL MEDICAL CORPORATION 215 S. STATE STREET STE: 100B Salt Lake City,  UT  84111
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-09
Decision Date2009-11-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M711CR19040 K091686 000
08809265155089 K091686 000
08809265152125 K091686 000
08809265152118 K091686 000
08809265152026 K091686 000
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08809265150169 K091686 000
08809265150152 K091686 000
08809265150138 K091686 000
08809265150121 K091686 000
08809265150046 K091686 000
08809265155140 K091686 000
08809265155195 K091686 000
08809265155218 K091686 000
M711CR16050 K091686 000
M711CR16040 K091686 000
M711CR16030 K091686 000
08809265155386 K091686 000
08809265155355 K091686 000
08809265155348 K091686 000
08809265155331 K091686 000
08809265155324 K091686 000
08809265155317 K091686 000
08809265155300 K091686 000
08806390800242 K091686 000

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