ISSYS PEDICLE SCREW SYSTEM

Appliance, Fixation, Spinal Interlaminal

CUSTOM SPINE, INC.

The following data is part of a premarket notification filed by Custom Spine, Inc. with the FDA for Issys Pedicle Screw System.

Pre-market Notification Details

Device IDK043522
510k NumberK043522
Device Name:ISSYS PEDICLE SCREW SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant CUSTOM SPINE, INC. PO BOX 1070 Conway,  NH  03818
ContactDebbie Iampietro
CorrespondentDebbie Iampietro
CUSTOM SPINE, INC. PO BOX 1070 Conway,  NH  03818
Product CodeKWP  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-20
Decision Date2005-01-14
Summary:summary

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