510(k) K073515
K073515 is an FDA 510(k) premarket notification submitted by Trans1 Incorporated for the device "TRANS1 FACET SCREW". The FDA issued a decision of Substantially Equivalent on Mar 11, 2008. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Trans1 Incorporated has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 11, 2008
- Date Received
- Dec 14, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Facet Screw Spinal Device
- Device Class
- Class U
- Review Panel
- OR
- Submission Type
- 510(k)