100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL— 510(k) K090103

Name: FDA 510(k) clearance K090103
Creator: U.S. Food and Drug Administration
Published: 2009-02-11

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K090103 for 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL, Substantially Equivalent on 2009-02-11. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code MAY
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2009-01-15
Decision date: 2009-02-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, 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.