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 IDK203222
510k NumberK203222
Device Name:PERLA TL Posterior Osteosynthesis System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant SPINEART 3 Chemin Du Pré Fleuri Plan Les Ouates,  CH 1228
ContactFranck Pennesi
CorrespondentFranck Pennesi
SPINEART 3 Chemin Du Pré Fleuri Plan Les Ouates,  CH 1228
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-02
Decision Date2020-12-17

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