Cleared Traditional

Restor3d Utility Wedge

K201314 · Restor3D, Inc. · Orthopedic

Jun 2021

Decision

395d

Days

Class 2

Risk

About This 510(k) Submission

K201314 is an FDA 510(k) clearance for the Restor3d Utility Wedge, a Bone Wedge (Class II — Special Controls, product code PLF), submitted by Restor3D, Inc. (Durham, US). The FDA issued a Cleared decision on June 17, 2021, 395 days after receiving the submission on May 18, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K201314 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 2020
Decision Date	June 17, 2021
Days to Decision	395 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.