SPARTAN S3 FACET SYSTEM— 510(k) K092568

Name: FDA 510(k) clearance K092568
Creator: U.S. Food and Drug Administration
Published: 2009-11-17

Substantially Equivalent

Amendia, Inc.

FDA 510(k) clearance K092568 for SPARTAN S3 FACET SYSTEM, Substantially Equivalent on 2009-11-17. Applicant: Amendia, Inc.. Device class: Unclassified.

Clearance details

Applicant: Amendia, Inc.
Product code: Code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2009-08-20
Decision date: 2009-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Apple Valley, MN, 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.