RPX TITANIUM CEMNT RESTRICTOR— 510(k) K020344

Name: FDA 510(k) clearance K020344
Creator: U.S. Food and Drug Administration
Published: 2002-05-02

Substantially Equivalent

Sulzer Spine-Tech

FDA 510(k) clearance K020344 for RPX TITANIUM CEMNT RESTRICTOR, Substantially Equivalent on 2002-05-02. Applicant: Sulzer Spine-Tech. Device class: 2.

Clearance details

Applicant: Sulzer Spine-Tech
Product code: Code JDK
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2002-02-01
Decision date: 2002-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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