CervAlign® Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Pioneer Surgical Technology, Inc.

The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. with the FDA for Cervalign® Anterior Cervical Plate System.

Pre-market Notification Details

Device IDK211408
510k NumberK211408
Device Name:CervAlign® Anterior Cervical Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant Pioneer Surgical Technology, Inc. 375 River Park Circle Marquette,  MI  49855
ContactJaclyn Holli
CorrespondentJaclyn Holli
Pioneer Surgical Technology, Inc. 375 River Park Circle Marquette,  MI  49855
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-06
Decision Date2021-06-23

Trademark Results [CervAlign]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CERVALIGN
CERVALIGN
88037029 not registered Live/Pending
Pioneer Surgical Technology, Inc.
2018-07-13

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