Implanet, a medical technology company designing vertebral implants, received FDA 510(k) regulatory clearance to market the JAZZ Band as usable with other posterior thoraco-lumbar fixation systems.
Here are five things to know:
1. Prior to this clearance, the JAZZ Band platform could only be used with the Implanet Spine System.
2. This clearance allows Implanet to conduct multicenter studies with the device.
3. Implanet hopes this clearance will allow the company to advance the technology's regulatory process in other countries, expanding Implanet's market presence.
4. Surgeons may now use the JAZZ Band with whichever posterior fixation system fits their needs best.
5. The JAZZ implant is intended to treat spinal pathologies requiring vertebral fusion surgery.