Transition Stabilization System
FDA 510(k) K073439 · Globus Medical, Inc.
510(k) numberK073439
Submission
- Device name
- Transition Stabilization System
- Applicant
- Globus Medical, Inc.
Audubon, PA, US - Received
- December 7, 2007
- Decision date
- February 20, 2009
- Decision
- Unknown (SESU)
- Type
- Traditional 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.
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| 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 |
| K091944 | Modification to: DSS Stabilization SystemNQP · Special | Paradigm Spine, LLC | 08/03/2009SE |
| K080241 | DDS Stabilization SystemNQP · Traditional | Paradigm Spine, LLC | 11/28/2008SESU |
| K080963 | DSS Stabilization SystemNQP · Special | Paradigm Spine | 05/02/2008SE |
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Questions and answers
When was Transition Stabilization System cleared by the FDA?
Transition Stabilization System (K073439) received a 510(k) decision of Unknown on February 20, 2009, 441 days after the submission was received.
What is the product code of K073439?
The FDA product code is NQP – Posterior Metal/Polymer Spinal System, Fusion, a Class II (moderate risk) device regulated under 21 CFR 888.3070.