Shiraz-Java Spinal Fixation System

FDA 510(k) K031265 · Spine Next SA

Substantially Equivalent

510(k) numberK031265

Submission

Device name
Shiraz-Java Spinal Fixation System
Applicant
Spine Next SA
Queenstown, MD, US
Received
April 21, 2003
Decision date
October 9, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNH – Orthosis, Spondylolisthesis Spinal Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code MNH

510(k)DeviceApplicantDecision
K162066Reliance Spinal Screw SystemMNH · Traditional Reliance Medical Systems, LLC12/02/2016SE
K162801CastleLoc Spinal Fixation SystemMNH · Special L&K BIOMED Co., Ltd.11/03/2016SE
K162143FixxSure® X-LinkMNH · Traditional Innovasis, Inc.09/23/2016SE
K161151Spinal fixation systemMNH · Traditional Canwell Medical Co., Ltd.09/21/2016SE
K162189ANAX™ 5.5 Spinal SystemMNH · Special U&I Corporation08/30/2016SE
K151362HC Spinal SystemMNH · Traditional Hung Chun Bio-S Co., Ltd.05/05/2016SE
K153404Zavation Spinal SystemMNH · Traditional Zavation, LLC04/21/2016SE
K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special Captiva Spine03/02/2016SE
K143013Spinal Inner Fixation SystemMNH · Traditional Changzhou Dingjian Medical Appliance Co., Ltd.12/11/2015SE
K151695Romeo posterior osteosynthesis systemMNH · Traditional Spineart09/10/2015SE

More from Spineart

510(k)DeviceDecision
K030871Fidji Large Cement RestrictorJDK · Traditional 12/22/2003SESU
K030767Fidji Small Cement RestrictorJDK · Traditional 12/22/2003SESU

Questions and answers

When was Shiraz-Java Spinal Fixation System cleared by the FDA?

Shiraz-Java Spinal Fixation System (K031265) received a 510(k) decision of Substantially Equivalent on October 9, 2003, 171 days after the submission was received.

What is the product code of K031265?

The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.