SeaSpine Spinous Process System— 510(k) K173334

Name: FDA 510(k) clearance K173334
Creator: U.S. Food and Drug Administration
Published: 2018-02-22

Substantially Equivalent

SeaSpine Orthopedics Corporation

FDA 510(k) clearance K173334 for SeaSpine Spinous Process System, Substantially Equivalent on 2018-02-22. Applicant: SeaSpine Orthopedics Corporation. Device class: 2.

Clearance details

Applicant: SeaSpine Orthopedics Corporation
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2017-10-23
Decision date: 2018-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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