LigaPASS® Spinal System, CD Horizon Spinal System— 510(k) K211057

Name: FDA 510(k) clearance K211057
Creator: U.S. Food and Drug Administration
Published: 2021-05-27

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K211057 for LigaPASS® Spinal System, CD Horizon Spinal System, Substantially Equivalent on 2021-05-27. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code OWI
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2021-04-09
Decision date: 2021-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, 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.