Tag: 510(k)
Centinel Spine receives FDA approval for two-level indications of prodisc L
Centinel Spine has announced US Food and Drug (FDA) approval of two-level indications for the prodisc L lumbar total disc replacement (TDR) system.
Centinel...
Cutting Edge Spine receives FDA 510(k) clearance for EVOL ha-DLIF system
Cutting Edge Spine has received 510(k) clearance from the US Food and Drug Administration (FDA) for its EVOL ha-DLIF direct lateral interbody fusion system.
The...
FDA 510(k) clearance for cervical and lumbar HA PEEK interbody...
The US Food and Drug Administration (FDA) has granted 510(k) clearance for both the ALTA ACDF interbody spacers (Astura Medical) and HALF DOME lumbar...
Camber Spine announces 510(k) approval of ENZA-A titanium ALIF
The US Food and Drug Administration (FDA) has given 510(k) clearance to Camber Spine to market its ENZA-A titanium anterior lumbar interbody fusion (ALIF)...
Medicrea files FDA 510(k) submission for 3D-printed titanium spinal devices
Medicrea has filed a 510(k) submission to the US Food and Drug Administration (FDA) for approval of the company’s 3D-printed titanium interbody devices, with...
Signus receives US FDA 510(k) clearance for Diplomat posterior pedicle screw...
Signus has received 510(k) clearance from the US Food and Drug Administration (FDA) for the new Diplomat pedicle screw system.
The Diplomat has been developed...