Cleared Traditional

PROSTEP TBC Implant System

K183620 · Wrightmedicaltechnologyinc · Orthopedic
Jun 2019
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K183620 is an FDA 510(k) clearance for the PROSTEP TBC Implant System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on June 6, 2019, 162 days after receiving the submission on December 26, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K183620 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2018
Decision Date June 06, 2019
Days to Decision 162 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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