Cleared Traditional

LONGBOW SPACER SYSTEM

K133717 · Life Spine · Orthopedic

Sep 2014

Decision

288d

Days

Class 2

Risk

About This 510(k) Submission

K133717 is an FDA 510(k) clearance for the LONGBOW SPACER SYSTEM, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Life Spine (Hoffman Est, US). The FDA issued a Cleared decision on September 19, 2014, 288 days after receiving the submission on December 5, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K133717 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2013
Decision Date	September 19, 2014
Days to Decision	288 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.