EQUATOR PLUS ACETABULAR CUP SYSTEM— 510(k) K051844

Name: FDA 510(k) clearance K051844
Creator: U.S. Food and Drug Administration
Published: 2005-10-07

Substantially Equivalent

Portland Orthopaedics Pty. , Ltd.

FDA 510(k) clearance K051844 for EQUATOR PLUS ACETABULAR CUP SYSTEM, Substantially Equivalent on 2005-10-07. Applicant: Portland Orthopaedics Pty. , Ltd.. Device class: 2.

Clearance details

Applicant: Portland Orthopaedics Pty. , Ltd.
Product code: Code MAY
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2005-07-07
Decision date: 2005-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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