Cleared Traditional

RTS Flexible 1 MPJ Implant w/Grommets

K153609 · In2bones USA, LLC · Orthopedic
Sep 2016
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K153609 is an FDA 510(k) clearance for the RTS Flexible 1 MPJ Implant w/Grommets, 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 September 8, 2016, 266 days after receiving the submission on December 17, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3720.

Submission Details

510(k) Number K153609 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2015
Decision Date September 08, 2016
Days to Decision 266 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