Cleared Special

PROSTEP MICA Screw System

K181377 · Wrightmedicaltechnologyinc · Orthopedic
Jan 2019
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K181377 is an FDA 510(k) clearance for the PROSTEP MICA Screw System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on January 11, 2019, 232 days after receiving the submission on May 24, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K181377 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2018
Decision Date January 11, 2019
Days to Decision 232 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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