Implanet received FDA 510(k) clearance and CE Mark approval for Jazz Lock®, a band-shaped implant to treat degenerative spinal disorders, including cervical. Commercial launch is underway.
Jazz Lock replaces the mechanism’s locking screw and connecting rod with a polyester sublaminar braid platform.
This represents Implanet’s entry into the treatment of spinal degenerative disorders, as well as its previous applications for deformity. Additional regulatory clearances in Implanet’s history:
Regulatory approval to market JAZZ Band in Brazil
FDA 510(k) clearance supporting use of JAZZ Band with posterior thoraco-lumbar fixation systems outside of the company’s own devices (September 2015)
CE Mark approval and FDA 510(k) clearance to market 3.5mm to 6mm JAZZ rods (May 2015)
Initial JAZZ 510(k) (2012)
Implanet received FDA 510(k) clearance and CE Mark approval for Jazz Lock®, a band-shaped implant to treat degenerative spinal disorders, including cervical. Commercial launch is underway.
Jazz Lock replaces the mechanism’s locking screw and connecting rod with a polyester sublaminar braid platform.
Implanet received FDA 510(k) clearance and CE Mark approval for Jazz Lock®, a band-shaped implant to treat degenerative spinal disorders, including cervical. Commercial launch is underway.
Jazz Lock replaces the mechanism’s locking screw and connecting rod with a polyester sublaminar braid platform.
This represents Implanet’s entry into the treatment of spinal degenerative disorders, as well as its previous applications for deformity. Additional regulatory clearances in Implanet’s history:
Regulatory approval to market JAZZ Band in Brazil
FDA 510(k) clearance supporting use of JAZZ Band with posterior thoraco-lumbar fixation systems outside of the company’s own devices (September 2015)
CE Mark approval and FDA 510(k) clearance to market 3.5mm to 6mm JAZZ rods (May 2015)
Initial JAZZ 510(k) (2012)
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