9 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CoLink View Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
ZenFlex
FDA UDI
Kerr Corporation·00195062029936·Rotary Files
mambo™ modular cervical plate system
FDA UDI
Ulrich GmbH & Co. KG·04052536008247·mambo extension plate L blue
OSDX HIP BMD SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 11, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·June 11, 2013
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH LTD./HUNTINGTON·Product code HQL·September 12, 2008
SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac Spinal Fixation System, Aspida" Anterior Lumbar Plating System, or the ILLlCO MIS Posterior Fixation System. Intervertebral body fusion device.
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code MAX·March 19, 2012