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Reimbursement / Regulatory

Camber Spine Receives FDA Clearance for ENZA Zero Profile ALIF Device -

Camber Spine Technologies received FDA 510(k) clearance to market the ENZA™ Zero Profile Anterior Interbody Fusion (ALIF) system.

ENZA is intended to treat degenerative disc disease, for use with bone graft and supplemental fixation systems. The product was co-developed with the Institute for Musculoskeletal Science & Education. 

This marks Camber’s eighth line of spinal implant systems to be released in the U.S. The company received its first FDA 510(k) clearance in 1Q13, for the TLS 5.0 Interbody Cage. The company was among our 2015 NASS Preview: Products and Companies to Watch and AAOS 2016: First-time Exhibitors to Meet.

Within 2Q16, the company has also launched the PROLIX™ SI Fusion and ORTHROS MIS™ Posterior Stabilization systems.

Sources: Camber Spine Technologies, ORTHOWORLD Inc.

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