FDA 510(k)

KeyLift Expandable Interlaminar Stabilization System

K-Number: K232484 · 2023-10-19

Decision Date2023-10-19

Product CodePEK

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

KeyLift Expandable Interlaminar Stabilization System is a medical device manufactured by Flospine. It received FDA 510(k) clearance on 2023-10-19 under approval number K232484. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KeyLift Expandable Interlaminar Stabilization System?

KeyLift Expandable Interlaminar Stabilization System is a medical device that received FDA 510(k) clearance on 2023-10-19. It is manufactured by Flospine. The 510(k) number is K232484.

When was KeyLift Expandable Interlaminar Stabilization System approved by the FDA?

KeyLift Expandable Interlaminar Stabilization System received FDA 510(k) clearance on 2023-10-19, under approval number K232484.

What company makes KeyLift Expandable Interlaminar Stabilization System?

KeyLift Expandable Interlaminar Stabilization System is manufactured by Flospine.

What is the FDA product code for KeyLift Expandable Interlaminar Stabilization System?

The FDA product code for KeyLift Expandable Interlaminar Stabilization System is PEK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.