Interventional Spine Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 8
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0941-2017 | Class II | G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-1 | November 22, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K160464 | Opticage(R) Expandable Interbody Fusion Device | April 4, 2016 |
| K152156 | Opticage Expandable Interbody Fusion Device | October 19, 2015 |
| K140716 | OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE | November 24, 2014 |
| K133583 | OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070 | February 10, 2014 |
| K132479 | OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 | September 19, 2013 |
| K113527 | OPTICAGE INTERBODY FUSION DEVICE | January 20, 2012 |
| K090767 | PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER | June 11, 2009 |
| K082795 | SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT | December 12, 2008 |