PYXIS 3D Titanium Cage System
K-Number: K223868 · 2023-04-26
ApplicantGS Medical Co., Ltd.
Decision Date2023-04-26
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
PYXIS 3D Titanium Cage System is a medical device manufactured by GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-04-26 under approval number K223868. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PYXIS 3D Titanium Cage System?
PYXIS 3D Titanium Cage System is a medical device that received FDA 510(k) clearance on 2023-04-26. It is manufactured by GS Medical Co., Ltd.. The 510(k) number is K223868.
When was PYXIS 3D Titanium Cage System approved by the FDA?
PYXIS 3D Titanium Cage System received FDA 510(k) clearance on 2023-04-26, under approval number K223868.
What company makes PYXIS 3D Titanium Cage System?
PYXIS 3D Titanium Cage System is manufactured by GS Medical Co., Ltd..
What is the FDA product code for PYXIS 3D Titanium Cage System?
The FDA product code for PYXIS 3D Titanium Cage System is MAX.
Related Clinical Trials
Other Devices by GS Medical Co., Ltd.
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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.