SABLE Expandable Spacer

Intervertebral Fusion Device With Bone Graft, Lumbar

Globus Medical Inc.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Sable Expandable Spacer.

Pre-market Notification Details

Device IDK192115
510k NumberK192115
Device Name:SABLE Expandable Spacer
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
ContactKelly J. Baker
CorrespondentKelly J. Baker
Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-06
Decision Date2020-01-14

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