PERLA® TL Posterior Osteosynthesis System

Thoracolumbosacral Pedicle Screw System

Spineart

The following data is part of a premarket notification filed by Spineart with the FDA for Perla® Tl Posterior Osteosynthesis System.

Pre-market Notification Details

Device IDK193396
510k NumberK193396
Device Name:PERLA® TL Posterior Osteosynthesis System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Spineart 3 Chemin Du Pre Fleuri Plan Les Ouates,  CH 1228
ContactFranck Pennesi
CorrespondentFranck Pennesi
Spineart 3 Chemin Du Pre Fleuri Plan Les Ouates,  CH 1228
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeOSH
Subsequent Product CodeOVD
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-06
Decision Date2020-02-05

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