ZYGAFIX SPINAL FACET SCREW SYSTEM— 510(k) K123932

Name: FDA 510(k) clearance K123932
Creator: U.S. Food and Drug Administration
Published: 2013-05-01

Substantially Equivalent

X-Spine Systems, Inc.

FDA 510(k) clearance K123932 for ZYGAFIX SPINAL FACET SCREW SYSTEM, Substantially Equivalent on 2013-05-01. Applicant: X-Spine Systems, Inc.. Device class: Unclassified.

Clearance details

Applicant: X-Spine Systems, Inc.
Product code: Code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2012-12-20
Decision date: 2013-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miamisburg, OH, 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.