Cleared Traditional

Tyber Medical Wedge System

K150394 · Tyber Medical, LLC · Orthopedic

Jul 2015

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K150394 is an FDA 510(k) clearance for the Tyber Medical Wedge System, a Bone Wedge (Class II — Special Controls, product code PLF), submitted by Tyber Medical, LLC (Morristown, US). The FDA issued a Cleared decision on July 28, 2015, 160 days after receiving the submission on February 18, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K150394 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 2015
Decision Date	July 28, 2015
Days to Decision	160 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PLF — Bone Wedge
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030
Definition	Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia.