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Quantity: 1;
Material - Implant: Zeniva® PEEK, Titanium and/or Tantalum;
Instrument: Polyarylamide, SS
XENCO MEDICAL LLC
XM-028-0819
In Commercial Distribution
- B064XM02808191 ()
- Spinal fixation plate, non-bioabsorbable
Quantity: 1;
Material - Implant: Zeniva® PEEK, Titanium and/or Tantalum;
Instrument: Polyarylamide, SS
XENCO MEDICAL LLC
XM-028-0817
In Commercial Distribution
- B064XM02808171 ()
- Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-028-0815
In Commercial Distribution
- B064XM02808151 ()
- Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-028-0811
In Commercial Distribution
- B064XM02808111 ()
- Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-028-0813
In Commercial Distribution
- B064XM02808131 ()
- Spinal fixation plate, non-bioabsorbable
Device Name: CERASORB® Ortho Foam
Mofidication: Mouldable Foam
Indication for Use:
Cerasorb® ORTHO Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process.
curasan AG
25x100x4 mm
In Commercial Distribution
- ECURCOM25100 ()
1 x 10.0cc
- Bone matrix implant, composite
Quad Channel Met-Traverse, 34mm x 10mm
Mios Marketing, LLC
Met-Traverse
In Commercial Distribution
- G2710620340100 ()
- Length: 34 Millimeter
- Depth: 10 Millimeter
34mm x 10mm
- Orthopaedic implant aiming/guiding block, single-use
Quad Channel Met-Traverse, 30mm x 14mm
Mios Marketing, LLC
Met-Traverse
In Commercial Distribution
- G2710620300140 ()
- Length: 30 Millimeter
- Depth: 14 Millimeter
30mm x 14mm
- Orthopaedic implant aiming/guiding block, single-use
Quad Channel Met-Traverse, 30mm x 10mm
Mios Marketing, LLC
Met-Traverse
In Commercial Distribution
- G2710620300100 ()
- Length: 30 Millimeter
- Depth: 10 Millimeter
30mm x 10mm
- Orthopaedic implant aiming/guiding block, single-use
StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (L VO) in head CTA images.
StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected L VO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow.
Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.
Circle Cardiovascular Imaging Inc
v2.x
- CT system application software