Implanet Receives FDA Clearance and CE Mark for New Jazz Lock Implant

By Julie A. Vetalice

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.

Source: Implanet

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)

 

Tags: 510(k) Clearance, CE Mark, Regulatory