POLARIS SPINAL SYSTEM— 510(k) K131615

Name: FDA 510(k) clearance K131615
Creator: U.S. Food and Drug Administration
Published: 2013-09-04

Substantially Equivalent

Biomet Spine (Aka Ebi, LLC)

FDA 510(k) clearance K131615 for POLARIS SPINAL SYSTEM, Substantially Equivalent on 2013-09-04. Applicant: Biomet Spine (Aka Ebi, LLC). Device class: 2.

Clearance details

Applicant: Biomet Spine (Aka Ebi, LLC)
Product code: Code OSH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2013-06-03
Decision date: 2013-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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