Interspinous Plate System— 510(k) K142378

Name: FDA 510(k) clearance K142378
Creator: U.S. Food and Drug Administration
Published: 2014-12-18

Substantially Equivalent

Precision Spine, Inc.

FDA 510(k) clearance K142378 for Interspinous Plate System, Substantially Equivalent on 2014-12-18. 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: 2014-08-26
Decision date: 2014-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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