Cleared Special

Tyber Medical Wedge System

K171327 · Tyber Medical, LLC · Orthopedic

May 2017

Decision

11d

Days

Class 2

Risk

About This 510(k) Submission

K171327 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 (Bethlehem, US). The FDA issued a Cleared decision on May 16, 2017, 11 days after receiving the submission on May 5, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K171327 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 05, 2017
Decision Date	May 16, 2017
Days to Decision	11 days
Submission Type	Special
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.