510(k) K072685
K072685 is an FDA 510(k) premarket notification submitted by N Spine, Inc. for the device "NGARDE SYSTEM". The FDA issued a decision of SESU on October 19, 2007. The device falls under product code NQP (Posterior Metal/Polymer Spinal System, Fusion), a Class II device regulated under 21 CFR 888.3070. N Spine, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- October 19, 2007
- Date Received
- September 21, 2007
- Clearance Type
- Special
- 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.