Oxford Performance Materials, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 4
- Compliance Actions
- 1
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K190915 | OsteoFab Suture Anchors | July 3, 2019 |
| K180064 | OsteoFab Patient Specific Cranial Device | July 27, 2018 |
| K161052 | OsteoFab Patient Specific Facial Device | July 20, 2016 |
| K142005 | SpineFab Vertebral Body Replacement (VBR) System | July 10, 2015 |
| K133809 | OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE | July 28, 2014 |
| K121818 | OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE | February 7, 2013 |