GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5— 510(k) K112097

Name: FDA 510(k) clearance K112097
Creator: U.S. Food and Drug Administration
Published: 2011-11-21

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K112097 for GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5, Substantially Equivalent on 2011-11-21. Applicant: Exactech, Inc.. Device class: Unclassified.

Clearance details

Applicant: Exactech, Inc.
Product code: Code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2011-07-22
Decision date: 2011-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, 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.