X Spine Systems Inc
X Spine Systems Inc appears in FDA public data with 7 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0127-2017, Class II) was initiated on May 17, 2016.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0127-2017 | Class II | Calix T PEEK Lumbar System, TLIF Trial | May 17, 2016 |
| Z-0125-2017 | Class II | Calix P PEEK Lumbar System, PLIF Trial | May 17, 2016 |
| Z-0126-2017 | Class II | Calix T PEEK Lumbar System, TLIF Rasp | May 17, 2016 |
| Z-0124-2017 | Class II | Calix P PEEK Lumbar System, PLIF Rasp | May 17, 2016 |
| Z-1823-2015 | Class II | Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexanders | April 7, 2015 |
| Z-1512-2015 | Class II | Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery c | March 11, 2015 |
| Z-2136-2014 | Class II | Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion | July 11, 2014 |