PFX SPINOUS PROCESS FIXATION SYSTEM— 510(k) K132765

Name: FDA 510(k) clearance K132765
Creator: U.S. Food and Drug Administration
Published: 2014-07-14

Substantially Equivalent

Innovasis, Inc.

FDA 510(k) clearance K132765 for PFX SPINOUS PROCESS FIXATION SYSTEM, Substantially Equivalent on 2014-07-14. Applicant: Innovasis, Inc.. Device class: 2.

Clearance details

Applicant: Innovasis, Inc.
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2013-09-04
Decision date: 2014-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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.