ABG III MONOLITHIC HIP STEM— 510(k) K123604

Clearance details

Applicant

Howmedica Osteonics Corp.

Product code

Code MAY

Device class

Class 2

Regulation

21 CFR 888.3353

Advisory panel

Orthopedic

Date received

2012-11-21

Decision date

2013-08-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mahwah, NJ, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123604.