DSS Stabilization System
FDA 510(k) K090099 · Paradigm Spine, LLC
510(k) numberK090099
Submission
- Device name
- DSS Stabilization System
- Applicant
- Paradigm Spine, LLC
Washington, DC, US - Received
- January 15, 2009
- Decision date
- June 19, 2009
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
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| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…NKB · Traditional | MANTIZ Co., Ltd. | 07/24/2026SE |
| K253943 | Tiger 2 SystemNKB · Traditional | Zavation Medical Products, LLC | 07/24/2026SE |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional | Alphatec Spine, Inc. | 07/14/2026SE |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 07/01/2026SE |
| K253045 | Socko Vimax Spinal Fixation SystemNKB · Traditional | Socko Medical Co., Ltd. | 06/17/2026SE |
| K251251 | ChanPin Pedicle Screw Spinal SystemNKB · Traditional | Chanpin Medtak Co., Ltd. | 06/09/2026SE |
| K260989 | Varion Thoracolumbar Fixation SystemNKB · Traditional | Kyocera Medical Technologies Inc. (KMTI) | 05/15/2026SE |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional | Globus Medical, Inc. | 05/07/2026SE |
| K261130 | AccelFix Spinal Fixation SystemNKB · Special | L&K BIOMED Co., Ltd. | 05/05/2026SE |
More from L&K BIOMED Co., Ltd.
| 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 |
| K091944 | Modification to: DSS Stabilization SystemNQP · Special | 08/03/2009SE |
Questions and answers
When was DSS Stabilization System cleared by the FDA?
DSS Stabilization System (K090099) received a 510(k) decision of Unknown on June 19, 2009, 155 days after the submission was received.
What is the product code of K090099?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.