Cleared Traditional

ShurFit Lumbar Interbody System

K212075 · Precision Spine, Inc. · Orthopedic

Dec 2021

Decision

159d

Days

Class 2

Risk

About This 510(k) Submission

K212075 is an FDA 510(k) clearance for the ShurFit Lumbar Interbody System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Precision Spine, Inc. (Pear, US). The FDA issued a Cleared decision on December 8, 2021, 159 days after receiving the submission on July 2, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K212075 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2021
Decision Date	December 08, 2021
Days to Decision	159 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.