The following data is part of a premarket notification filed by Oxford Performance Materials with the FDA for Spinefab Vertebral Body Replacement (vbr) System.
| Device ID | K142005 |
| 510k Number | K142005 |
| Device Name: | SpineFab Vertebral Body Replacement (VBR) System |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | OXFORD PERFORMANCE MATERIALS 30 S SATELLITE ROAD South Windsor, CT 06074 |
| Contact | Leigh Ayres |
| Correspondent | Leigh Ayres OXFORD PERFORMANCE MATERIALS 30 S SATELLITE ROAD South Windsor, CT 06074 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-23 |
| Decision Date | 2015-07-10 |
| Summary: | summary |