HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments

Intervertebral Fusion Device With Bone Graft, Cervical

Globus Medical Inc.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Hedron Cervical Spacers, Hedron Lumbar Spacers, Sable Expandable Spacer, Excelsiusgps Instruments.

Pre-market Notification Details

Device IDK222270
510k NumberK222270
Device Name:HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
ContactKelly Baker
CorrespondentKelly Baker
Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
Product CodeODP  
Subsequent Product CodeMAX
Subsequent Product CodeOLO
Subsequent Product CodeOVD
Subsequent Product CodeOVE
Subsequent Product CodePHM
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-29
Decision Date2022-10-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.