Sterispine™ PS

Thoracolumbosacral Pedicle Screw System

Safe Orthopaedics

The following data is part of a premarket notification filed by Safe Orthopaedics with the FDA for Sterispine™ Ps.

Pre-market Notification Details

Device IDK201648
510k NumberK201648
Device Name:Sterispine™ PS
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Safe Orthopaedics Parc Des Bellevues, Allee R. Luxembourg-Bat. Californie Eragny Sur Oise,  FR 95610
ContactPierre Dumouchel
CorrespondentPierre Dumouchel
Safe Orthopaedics Parc Des Bellevues, Le Californie - Allee Rosa Luxemburg Eragny Sur Oise,  FR 95610
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-18
Decision Date2020-07-30

Trademark Results [Sterispine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STERISPINE
STERISPINE
90720535 not registered Live/Pending
SAFE ORTHOPAEDICS
2021-05-19
STERISPINE
STERISPINE
85356563 4196928 Dead/Cancelled
SAFE ORTHOPAEDICS
2011-06-27

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