510(k) K072969
K072969 is an FDA 510(k) premarket notification submitted by Paradigm Spine, LLC for the device "DSS". The FDA issued a decision of SESU on January 24, 2008. The device falls under product code NQP (Posterior Metal/Polymer Spinal System, Fusion), a Class II device regulated under 21 CFR 888.3070. Paradigm Spine, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- January 24, 2008
- Date Received
- October 22, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Posterior Metal/Polymer Spinal System, Fusion
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
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.