Modification to: DSS Stabilization System
FDA 510(k) K091944 · Paradigm Spine, LLC
510(k) numberK091944
Submission
- Device name
- Modification to: DSS Stabilization System
- Applicant
- Paradigm Spine, LLC
Washington, DC, US - Received
- June 30, 2009
- Decision date
- August 3, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQP – Posterior Metal/Polymer Spinal System, Fusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Other 510(k)s with product code NQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203678 | CD HORIZON Spinal SystemNQP · Special | Medtronic Sofamor Danek USA, Inc. | 01/15/2021SE |
| K191066 | CD Horizon Astute Spinal SystemNQP · Traditional | Medtronic Sofamor Danek USA, Inc. | 10/03/2019SE |
| K182928 | CD Horizon Spinal SystemNQP · Traditional | Medtronic Sofamor Danek USA, Inc. | 01/11/2019SE |
| K133164 | Dynesys Top-Loading Spinal SystemNQP · Traditional | Zimmer Spine, Inc. | 01/16/2014SE |
| K101704 | Zimmer Dto Pin Press InstrumentNQP · Special | Zimmer Spine, Inc. | 08/18/2010SE |
| K101083 | DSS Stabilization SystemNQP · Special | Paradigm Spine, LLC | 07/02/2010SESU |
| K092234 | Dynesys Top-Loading Spinal SystemNQP · Traditional | Zimmer Spine, Inc. | 10/01/2009SE |
| K073439 | Transition Stabilization SystemNQP · Traditional | Globus Medical, Inc. | 02/20/2009SESU |
| K080241 | DDS Stabilization SystemNQP · Traditional | Paradigm Spine, LLC | 11/28/2008SESU |
| K080963 | DSS Stabilization SystemNQP · Special | Paradigm Spine | 05/02/2008SE |
More from Paradigm Spine
| 510(k) | Device | Decision |
|---|---|---|
| K213493 | Fortilink with TiPlus TechnologyODP · Traditional | 01/27/2022SE |
| K201453 | Fortilink Cages with TiPlus TechnologyMAX · Traditional | 10/07/2020SE |
| K201704 | CoFix SystemPEK · Special | 08/04/2020SE |
| K153302 | coflex-IFPEK · Traditional | 09/08/2016SE |
| K120491 | DSS Stabilization System-RigidMNH · Traditional | 05/09/2012SESU |
| K112595 | Coflex-FKWP · Traditional | 02/13/2012SE |
| K113625 | DSS Stabilization SystemNKB · Special | 01/10/2012SESU |
| K093438 | Paradigm Interspinous Fusion PlateKWP · Traditional | 10/06/2010SE |
| K101083 | DSS Stabilization SystemNQP · Special | 07/02/2010SESU |
| K090099 | DSS Stabilization SystemNKB · Traditional | 06/19/2009SESU |
Questions and answers
When was Modification to: DSS Stabilization System cleared by the FDA?
Modification to: DSS Stabilization System (K091944) received a 510(k) decision of Substantially Equivalent on August 3, 2009, 34 days after the submission was received.
What is the product code of K091944?
The FDA product code is NQP – Posterior Metal/Polymer Spinal System, Fusion, a Class II (moderate risk) device regulated under 21 CFR 888.3070.