510(k) K123093
K123093 is an FDA 510(k) premarket notification submitted by Southern Spine, LLC for the device "STABILINK MIS SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on Dec 20, 2012. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Southern Spine, LLC has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 20, 2012
- Date Received
- Oct 2, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Spinal Interlaminal
- Device Class
- Class II
- Regulation Number
- 888.3050
- Review Panel
- OR
- Submission Type
- 510(k)