510(k) K082992
K082992 is an FDA 510(k) premarket notification submitted by Spinal Elements, Inc. for the device "AXXION LIGHT GUIDE". The FDA issued a decision of Substantially Equivalent on February 18, 2009. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Spinal Elements, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2009
- Date Received
- October 7, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Fiberoptic
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type