SpineFrontier Lumbar Interbody Fusion Device System
K-Number: K193106 · 2020-06-19
ApplicantSpinefrontier, Inc.
Decision Date2020-06-19
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SpineFrontier Lumbar Interbody Fusion Device System is a medical device manufactured by Spinefrontier, Inc.. It received FDA 510(k) clearance on 2020-06-19 under approval number K193106. 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 SpineFrontier Lumbar Interbody Fusion Device System?
SpineFrontier Lumbar Interbody Fusion Device System is a medical device that received FDA 510(k) clearance on 2020-06-19. It is manufactured by Spinefrontier, Inc.. The 510(k) number is K193106.
When was SpineFrontier Lumbar Interbody Fusion Device System approved by the FDA?
SpineFrontier Lumbar Interbody Fusion Device System received FDA 510(k) clearance on 2020-06-19, under approval number K193106.
What company makes SpineFrontier Lumbar Interbody Fusion Device System?
SpineFrontier Lumbar Interbody Fusion Device System is manufactured by Spinefrontier, Inc..
What is the FDA product code for SpineFrontier Lumbar Interbody Fusion Device System?
The FDA product code for SpineFrontier Lumbar Interbody Fusion Device System is MAX.
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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.