Largo PEEK Interbody System
K-Number: K193255 · 2020-02-20
ApplicantFlospine, LLC
Decision Date2020-02-20
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Largo PEEK Interbody System is a medical device manufactured by Flospine, LLC. It received FDA 510(k) clearance on 2020-02-20 under approval number K193255. 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 Largo PEEK Interbody System?
Largo PEEK Interbody System is a medical device that received FDA 510(k) clearance on 2020-02-20. It is manufactured by Flospine, LLC. The 510(k) number is K193255.
When was Largo PEEK Interbody System approved by the FDA?
Largo PEEK Interbody System received FDA 510(k) clearance on 2020-02-20, under approval number K193255.
What company makes Largo PEEK Interbody System?
Largo PEEK Interbody System is manufactured by Flospine, LLC.
What is the FDA product code for Largo PEEK Interbody System?
The FDA product code for Largo PEEK Interbody System is MAX.
Related Clinical Trials
Related Devices (Code: MAX)
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K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP
K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.
K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.
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.