Claris Plate System

FDA 510(k) K010369 · Ortho Tec, LLC

Substantially Equivalent

510(k) numberK010369

Submission

Device name
Claris Plate System
Applicant
Ortho Tec, LLC
Beverly Hills, CA, US
Received
February 7, 2001
Decision date
May 8, 2001
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
K040514Eovia Calcium Phosphate CeramicMQV · Traditional 05/03/2004SE
K040346Modification to Oria Top Clip SystemMNI · Special 03/12/2004SE
K030958Oria Spinal System, Domino and Tube ConnectorsMNI · Traditional 11/20/2003SE
K031471Oria Spinal Clip System, Lateral Intermediate Connector, Model AL01KWP · Traditional 10/10/2003SE
K023884Modification Oria Spinal SystemKWP · Traditional 08/20/2003SE
K023378Oria ClarisMNH · Traditional 06/27/2003SE
K031452Oria Spinal Clip System, Sacral Connector, Models CA03 and AO03KWP · Special 06/18/2003SE
K030500Oria ZenithKWQ · Special 03/20/2003SE
K023377Oria Cervical PlatesKWQ · Traditional 03/04/2003SE
K030253Oria Spinal Clip System, Lengthened Lateral Connector, Model AL06KWP · Special 02/21/2003SE

Questions and answers

When was Claris Plate System cleared by the FDA?

Claris Plate System (K010369) received a 510(k) decision of Substantially Equivalent on May 8, 2001, 90 days after the submission was received.

What is the product code of K010369?

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