KeyLift Expandable Interlaminar Stabilization System— 510(k) K232484

Name: FDA 510(k) clearance K232484
Creator: U.S. Food and Drug Administration
Published: 2023-10-19

Substantially Equivalent

Flospine

FDA 510(k) clearance K232484 for KeyLift Expandable Interlaminar Stabilization System, Substantially Equivalent on 2023-10-19. Applicant: Flospine. Device class: 2.

Clearance details

Applicant: Flospine
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2023-08-16
Decision date: 2023-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.