SPINESMITH CIMPLICITY SPINAL SYSTEM

Spinal Vertebral Body Replacement Device

SPINE SMITH PARTNERS L.P.

The following data is part of a premarket notification filed by Spine Smith Partners L.p. with the FDA for Spinesmith Cimplicity Spinal System.

Pre-market Notification Details

Device IDK080971
510k NumberK080971
Device Name:SPINESMITH CIMPLICITY SPINAL SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant SPINE SMITH PARTNERS L.P. 8140 N. MOPAC BLDG II, SUITE 120 Austin,  TX  78759
ContactRobert Jones
CorrespondentRobert Jones
SPINE SMITH PARTNERS L.P. 8140 N. MOPAC BLDG II, SUITE 120 Austin,  TX  78759
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-04
Decision Date2008-07-02
Summary:summary

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