Plateau Spacer System
K-Number: K182470 · 2018-11-26
ApplicantLife Spine
Decision Date2018-11-26
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Plateau Spacer System is a medical device manufactured by Life Spine. It received FDA 510(k) clearance on 2018-11-26 under approval number K182470. 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 Plateau Spacer System?
Plateau Spacer System is a medical device that received FDA 510(k) clearance on 2018-11-26. It is manufactured by Life Spine. The 510(k) number is K182470.
When was Plateau Spacer System approved by the FDA?
Plateau Spacer System received FDA 510(k) clearance on 2018-11-26, under approval number K182470.
What company makes Plateau Spacer System?
Plateau Spacer System is manufactured by Life Spine.
What is the FDA product code for Plateau Spacer System?
The FDA product code for Plateau Spacer System is MAX.
Other Devices by Life Spine
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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
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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.