Precision Spine Interspinous Plate System— 510(k) K160568

Name: FDA 510(k) clearance K160568
Creator: U.S. Food and Drug Administration
Published: 2016-05-04

Substantially Equivalent

Precision Spine, Inc.

FDA 510(k) clearance K160568 for Precision Spine Interspinous Plate System, Substantially Equivalent on 2016-05-04. Applicant: Precision Spine, Inc.. Device class: 2.

Clearance details

Applicant: Precision Spine, Inc.
Product code: Product code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2016-02-29
Decision date: 2016-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pearl, MS, US

Download summary PDF View on FDA.gov ↗

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