DSS Stabilization System-Rigid

FDA 510(k) K120491 · Paradigm Spine, LLC

Unknown

510(k) numberK120491

Submission

Device name
DSS Stabilization System-Rigid
Applicant
Paradigm Spine, LLC
Washington, DC, US
Received
February 17, 2012
Decision date
May 9, 2012
Decision
Unknown (SESU)
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
K213493Fortilink with TiPlus TechnologyODP · Traditional 01/27/2022SE
K201453Fortilink Cages with TiPlus TechnologyMAX · Traditional 10/07/2020SE
K201704CoFix SystemPEK · Special 08/04/2020SE
K153302coflex-IFPEK · Traditional 09/08/2016SE
K112595Coflex-FKWP · Traditional 02/13/2012SE
K113625DSS Stabilization SystemNKB · Special 01/10/2012SESU
K093438Paradigm Interspinous Fusion PlateKWP · Traditional 10/06/2010SE
K101083DSS Stabilization SystemNQP · Special 07/02/2010SESU
K091944Modification to: DSS Stabilization SystemNQP · Special 08/03/2009SE
K090099DSS Stabilization SystemNKB · Traditional 06/19/2009SESU

Questions and answers

When was DSS Stabilization System-Rigid cleared by the FDA?

DSS Stabilization System-Rigid (K120491) received a 510(k) decision of Unknown on May 9, 2012, 82 days after the submission was received.

What is the product code of K120491?

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