INTEGRA INTERSPINOUS PROCESS SYSTEM— 510(k) K121924

Name: FDA 510(k) clearance K121924
Creator: U.S. Food and Drug Administration
Published: 2013-09-04

Substantially Equivalent

Seaspine, Inc.

FDA 510(k) clearance K121924 for INTEGRA INTERSPINOUS PROCESS SYSTEM, Substantially Equivalent on 2013-09-04. Applicant: Seaspine, Inc.. Device class: 2.

Clearance details

Applicant: Seaspine, Inc.
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2012-07-02
Decision date: 2013-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

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