DISTAL VOLAR RADIUS PLATING SYSTEMS— 510(k) K112345

Clearance details

Applicant

Medos International SARL

Product code

Code LXT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2011-08-15

Decision date

2011-10-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112345.