SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System

Spinous Process Plate

Globus Medical Inc.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Sp-fix® Spinous Process Fixation Plate, Relieve® Laminoplasty Fixation System.

Pre-market Notification Details

Device IDK180156
510k NumberK180156
Device Name:SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
ClassificationSpinous Process Plate
Applicant Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
ContactLori Burns
CorrespondentLori Burns
Globus Medical Inc. 2560 General Armistead Avenue Audubon,  PA  19403
Product CodePEK  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-19
Decision Date2018-03-07
Summary:summary

Trademark Results [SP-Fix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SP-FIX
SP-FIX
85051909 4094316 Live/Registered
Globus Medical, Inc.
2010-06-01

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