VERTIFLEX SPINAL SCREW SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

VERTIFLEX (TM), INCORPORATED

The following data is part of a premarket notification filed by Vertiflex (tm), Incorporated with the FDA for Vertiflex Spinal Screw System.

Pre-market Notification Details

Device IDK062670
510k NumberK062670
Device Name:VERTIFLEX SPINAL SCREW SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant VERTIFLEX (TM), INCORPORATED 1954 KELLOGG AVENUE, SUITE 100 Carlsbad,  CA  92008
ContactSteve Reitzler
CorrespondentSteve Reitzler
VERTIFLEX (TM), INCORPORATED 1954 KELLOGG AVENUE, SUITE 100 Carlsbad,  CA  92008
Product CodeMNH  
Subsequent Product CodeMNI
Subsequent Product CodeNKB
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-07
Decision Date2007-01-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00840996181297 K062670 000

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