510(k) K112595
K112595 is an FDA 510(k) premarket notification submitted by Paradigm Spine, LLC for the device "COFLEX-F". The FDA issued a decision of Substantially Equivalent on February 13, 2012. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Paradigm Spine, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2012
- Date Received
- September 7, 2011
- 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