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 IDK213470
510k NumberK213470
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 Received2021-10-28
Decision Date2022-01-21

Trademark Results [PERLA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PERLA
PERLA
98533824 not registered Live/Pending
El Carmen, Inc.
2024-05-03
PERLA
PERLA
97858477 not registered Live/Pending
2904802 Canada Inc
2023-03-27
PERLA
PERLA
97847591 not registered Live/Pending
El Carmen, Inc.
2023-03-20
PERLA
PERLA
97748960 not registered Live/Pending
El Carmen, Inc.
2023-01-10
PERLA
PERLA
97748932 not registered Live/Pending
El Carmen, Inc.
2023-01-10
PERLA
PERLA
97748920 not registered Live/Pending
El Carmen, Inc.
2023-01-10
PERLA
PERLA
97748900 not registered Live/Pending
El Carmen, Inc.
2023-01-10
PERLA
PERLA
97748766 not registered Live/Pending
El Carmen, Inc.
2023-01-10
PERLA
PERLA
97728735 not registered Live/Pending
Acosta, Perla
2022-12-22
PERLA
PERLA
97728735 not registered Live/Pending
Acosta, Perla
2022-12-22
PERLA
PERLA
97599549 not registered Live/Pending
Perla on Broadway Homeowners Association
2022-09-20
PERLA
PERLA
97059035 not registered Live/Pending
El Carmen, Inc.
2021-10-04

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