SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE— 510(k) K031428

Clearance details

Applicant

Synthes (Usa)

Product code

Code LXT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2003-05-06

Decision date

2003-08-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Paoli, PA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031428.