PERLA® Posterior Occipito-Cervico-Thoracic Fixation System

Posterior Cervical Screw System

SPINEART

The following data is part of a premarket notification filed by Spineart with the FDA for Perla® Posterior Occipito-cervico-thoracic Fixation System.

Pre-market Notification Details

Device IDK200571
510k NumberK200571
Device Name:PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
ClassificationPosterior Cervical 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 CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-04
Decision Date2020-05-01

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