510(k) K042600
K042600 is an FDA 510(k) premarket notification submitted by Spineworks, LLC for the device "STANSION MATRIX". The FDA issued a decision of Substantially Equivalent on February 18, 2005. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Spineworks, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2005
- Date Received
- September 23, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spinal Vertebral Body Replacement Device
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type