Cleared Traditional

THP Hip Fracture Plating System

K173826 · Biomet, Inc. · Orthopedic
Feb 2018
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K173826 is an FDA 510(k) clearance for the THP Hip Fracture Plating System, a Device, Fixation, Proximal Femoral, Implant (Class II — Special Controls, product code JDO), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 7, 2018, 51 days after receiving the submission on December 18, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K173826 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2017
Decision Date February 07, 2018
Days to Decision 51 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDO — Device, Fixation, Proximal Femoral, Implant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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