PRIME FEMORAL CEMENT PLUG— 510(k) K955751

Name: FDA 510(k) clearance K955751
Creator: U.S. Food and Drug Administration
Published: 1996-01-26

Substantially Equivalent

Orthopaedic Innovations, Inc.

FDA 510(k) clearance K955751 for PRIME FEMORAL CEMENT PLUG, Substantially Equivalent on 1996-01-26. Applicant: Orthopaedic Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Orthopaedic Innovations, Inc.
Product code: Code LZN
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1995-12-20
Decision date: 1996-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.