Inspan ScrewLES Fusion System— 510(k) K213266

Name: FDA 510(k) clearance K213266
Creator: U.S. Food and Drug Administration
Published: 2021-12-03

Substantially Equivalent

Lespine Innovations, LLC

FDA 510(k) clearance K213266 for Inspan ScrewLES Fusion System, Substantially Equivalent on 2021-12-03. Applicant: Lespine Innovations, LLC. Device class: 2.

Clearance details

Applicant: Lespine Innovations, LLC
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2021-09-30
Decision date: 2021-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malden, MA, US

Download summary PDF View on FDA.gov ↗

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