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FDA 510(k)

KeyLift™ Expandable Interlaminar Stabilization System

K-Number: K232484 · 2023-10-19

ApplicantFlospine
Decision Date2023-10-19
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KeyLift™ Expandable Interlaminar Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is Flospine. It received FDA 510(k) clearance on 2023-10-19 under 510(k) 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. The listed applicant is Flospine. The 510(k) number is K232484.

When did KeyLift™ Expandable Interlaminar Stabilization System receive FDA 510(k) clearance?

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

Who is the listed applicant for KeyLift™ Expandable Interlaminar Stabilization System?

The FDA 510(k) record lists Flospine as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Flospine as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223231Ti-Largo Cervical Interbody SystemK210182PANAMA™ Anterior Cervical Plate (ACP) SystemK193255Largo PEEK Interbody System

Related Devices (Code: PEK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLCK234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3Spinal Simplicity, LLCK233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLCK231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.K223790Huvex Interspinous Fusion SystemDio Medical Corp.K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5Spinal Simplicity, LLC

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.

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