AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM— 510(k) K133052

Name: FDA 510(k) clearance K133052
Creator: U.S. Food and Drug Administration
Published: 2013-12-20

Substantially Equivalent

Nuvasive, Inc.

FDA 510(k) clearance K133052 for AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM, Substantially Equivalent on 2013-12-20. Applicant: Nuvasive, Inc.. Device class: 2.

Clearance details

Applicant: Nuvasive, Inc.
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2013-09-27
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.