ALTA Anterior Cervical Corpectomy System— 510(k) K190426

Name: FDA 510(k) clearance K190426
Creator: U.S. Food and Drug Administration
Published: 2019-10-24

Substantially Equivalent

Astura Medical, LLC

FDA 510(k) clearance K190426 for ALTA Anterior Cervical Corpectomy System, Substantially Equivalent on 2019-10-24. Applicant: Astura Medical, LLC. Device class: 2.

Clearance details

Applicant: Astura Medical, LLC
Product code: Code PLR
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2019-02-22
Decision date: 2019-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, 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.