GEO Bone Screw System
K-Number: K161904 · 2017-01-18
ApplicantGramercy Extremity Orthopeidics, LLC
Decision Date2017-01-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
GEO Bone Screw System is a medical device manufactured by Gramercy Extremity Orthopeidics, LLC. It received FDA 510(k) clearance on 2017-01-18 under approval number K161904. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GEO Bone Screw System?
GEO Bone Screw System is a medical device that received FDA 510(k) clearance on 2017-01-18. It is manufactured by Gramercy Extremity Orthopeidics, LLC. The 510(k) number is K161904.
When was GEO Bone Screw System approved by the FDA?
GEO Bone Screw System received FDA 510(k) clearance on 2017-01-18, under approval number K161904.
What company makes GEO Bone Screw System?
GEO Bone Screw System is manufactured by Gramercy Extremity Orthopeidics, LLC.
What is the FDA product code for GEO Bone Screw System?
The FDA product code for GEO Bone Screw System is HWC. This falls under the Cardiovascular category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.