Implanet received FDA 510(k) clearance to market JAZZ Cap®, its system to secure spinal screws in poor quality bone for vertebral fusion procedures.
JAZZ Cap was developed for the treatment of degenerative conditions in adult patients. The clearance plays a key role in in the private label distribution agreement signed with SeaSpine earlier this year, whereby SeaSpine has exclusive rights to sell JAZZ products, including JAZZ Cap, under its own brand name.
This is the company's tenth 510(k) for components in the JAZZ portfolio, and it follows the product's CE Mark Approval that was secured in 4Q18.
Sources: Implanet; ORTHOWORLD Inc.