SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

SPINEVISION, S.A.

The following data is part of a premarket notification filed by Spinevision, S.a. with the FDA for Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.l.i.s. Pedicle Screw Fixation System.

Pre-market Notification Details

Device IDK133575
510k NumberK133575
Device Name:SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant SPINEVISION, S.A. Antony Parc II 10 Place Du General De Gaulle Antony Cedex,  FR 92184
ContactJ.d. Webb
CorrespondentJ.d. Webb
SPINEVISION, S.A. Antony Parc II 10 Place Du General De Gaulle Antony Cedex,  FR 92184
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-20
Decision Date2014-06-30
Summary:summary

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