Cleared Traditional

LimaCorporate Kirschner Wire

K203475 · Lima Corporate S.P.A. · Orthopedic
Feb 2021
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K203475 is an FDA 510(k) clearance for the LimaCorporate Kirschner Wire, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Lima Corporate S.P.A. (San Daniele Del Friuli, IT). The FDA issued a Cleared decision on February 5, 2021, 72 days after receiving the submission on November 25, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K203475 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2020
Decision Date February 05, 2021
Days to Decision 72 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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