FacetBRIDGE® System— 510(k) K161798

Name: FDA 510(k) clearance K161798
Creator: U.S. Food and Drug Administration
Published: 2016-08-04

Substantially Equivalent

Ldr Spine USA, Inc.

FDA 510(k) clearance K161798 for FacetBRIDGE® System, Substantially Equivalent on 2016-08-04. Applicant: Ldr Spine USA, Inc.. Device class: Unclassified.

Clearance details

Applicant: Ldr Spine USA, Inc.
Product code: Code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2016-06-30
Decision date: 2016-08-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, 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.