Oxford Performance Materials achieved FDA 510(k) clearance for the SpineFab VBR implant system.
Here are five things to know:
1. The SpineFab system is the first FDA-cleared three-dimensional printed load bearing polymer device for long-term implantation.
2. This is OPM’s third OsteoFab FDA clearance. The first was achieved in February 2013 with the OsteoFab Patient-Specific Cranial Device. Last year the company achieved clearance for the OsteoFab Patient-Specific Facial Device.