510(k) K050965
K050965 is an FDA 510(k) premarket notification submitted by Trans1 Incorporated for the device "TRANS1 AXIALIF SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 14, 2005. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Trans1 Incorporated has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 14, 2005
- Date Received
- Apr 18, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Spinal Intervertebral Body
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type
- 510(k)