HAPPE Spine received FDA 510(k) clearance to market the INTEGRATE-C Interbody Fusion System.
Powered by the HAPPE platform, INTEGRATE-C is reported to be the first interbody fusion cage that is fully integrated with porosity and hydroxyapatite to provide a superior healing environment. The interconnected, cancellous porosity promotes bone ingrowth from endplate-to-endplate. Hydroxyapatite is exposed on all surfaces to promote cell signaling and bone on-growth. The INTEGRATE-C is both radiolucent and radiovisible for superior intra-operative and post-operative imaging.
The INTEGRATE-C system offers an array of sizes and lordotic angles to accommodate patient anatomy. The company’s commercialization strategy is presently focused on a limited user release to establish efficacy with clinical data.
Andrew Iott, CEO of HAPPE Spine, said, “We are very excited to have gained 510(k) clearance for HAPPE’s new innovative technology and look forward to launching game-changing product solutions in the near future. The combination of cancellous porosity with hydroxyapatite exposed on all pore surfaces represents a true leap forward in interbody fusion devices.”
HAPPE Spine received FDA 510(k) clearance to market the INTEGRATE-C Interbody Fusion System.
Powered by the HAPPE platform, INTEGRATE-C is reported to be the first interbody fusion cage that is fully integrated with porosity and hydroxyapatite to provide a superior healing environment. The interconnected, cancellous porosity promotes bone...
HAPPE Spine received FDA 510(k) clearance to market the INTEGRATE-C Interbody Fusion System.
Powered by the HAPPE platform, INTEGRATE-C is reported to be the first interbody fusion cage that is fully integrated with porosity and hydroxyapatite to provide a superior healing environment. The interconnected, cancellous porosity promotes bone ingrowth from endplate-to-endplate. Hydroxyapatite is exposed on all surfaces to promote cell signaling and bone on-growth. The INTEGRATE-C is both radiolucent and radiovisible for superior intra-operative and post-operative imaging.
The INTEGRATE-C system offers an array of sizes and lordotic angles to accommodate patient anatomy. The company’s commercialization strategy is presently focused on a limited user release to establish efficacy with clinical data.
Andrew Iott, CEO of HAPPE Spine, said, “We are very excited to have gained 510(k) clearance for HAPPE’s new innovative technology and look forward to launching game-changing product solutions in the near future. The combination of cancellous porosity with hydroxyapatite exposed on all pore surfaces represents a true leap forward in interbody fusion devices.”
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