Cleared Traditional

RTS Lesser MTP Implant System

K173491 · In2bones USA, LLC · Orthopedic
Feb 2018
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K173491 is an FDA 510(k) clearance for the RTS Lesser MTP Implant System, a Prosthesis, Toe, Constrained, Polymer (Class II — Special Controls, product code KWH), submitted by In2bones USA, LLC (Memphis, US). The FDA issued a Cleared decision on February 23, 2018, 102 days after receiving the submission on November 13, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3720.

Submission Details

510(k) Number K173491 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2017
Decision Date February 23, 2018
Days to Decision 102 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWH — Prosthesis, Toe, Constrained, Polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3720