GPS Cervical Spacers

Intervertebral Fusion Device With Bone Graft, Cervical

G Surgical LLC

The following data is part of a premarket notification filed by G Surgical Llc with the FDA for Gps Cervical Spacers.

Pre-market Notification Details

Device IDK210890
510k NumberK210890
Device Name:GPS Cervical Spacers
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant G Surgical LLC 9433 Bee Cave Road Building 3, Suite 101-A Austin,  TX  78733
ContactDonald Grafton
CorrespondentKaren E. Warden
BackRoads Consulting PO Box 566 Chesterland,  OH  44026
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-25
Decision Date2021-04-23

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