CEMSTOP CEMENT RESTRICTOR— 510(k) K993841

Name: FDA 510(k) clearance K993841
Creator: U.S. Food and Drug Administration
Published: 2000-05-04

Substantially Equivalent

Encore Orthopedics, Inc.

FDA 510(k) clearance K993841 for CEMSTOP CEMENT RESTRICTOR, Substantially Equivalent on 2000-05-04. Applicant: Encore Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Encore Orthopedics, Inc.
Product code: Code LZN
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1999-11-12
Decision date: 2000-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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