Cleared Traditional

ShurFit 2C Lumbar Interbody Fusion System

K171657 · Precision Spine, Inc. · Orthopedic

Aug 2017

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K171657 is an FDA 510(k) clearance for the ShurFit 2C Lumbar Interbody Fusion 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 August 11, 2017, 67 days after receiving the submission on June 5, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K171657 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 2017
Decision Date	August 11, 2017
Days to Decision	67 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.