SEARCH RESULTS FOR: Origin(1213 results)
icotec Instrument Implant Holder for Tamping
icotec AG
38-036
In Commercial Distribution
- 07640164841830 ()
38-036
- Bone graft packing block
primaLOK SP 18mm Implant Assembly, Sterile
The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0118-00
In Commercial Distribution
- 00813210021778 ()
- Height: 18 Millimeter
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 12mm Implant Assembly, Sterile
The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0112-00
In Commercial Distribution
- 00813210021754 ()
- Height: 12 Millimeter
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 10mm Implant Assembly, Sterile
The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0110-00
In Commercial Distribution
- 00813210021747 ()
- Height: 10 Millimeter
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 6mm Implant Assembly, Sterile
The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0106-00
In Commercial Distribution
- 00813210021723 ()
- Height: 6 Millimeter
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-L is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-L is designed to be implanted bi-laterally via posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-L may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion. VariLift-L is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Wenzel Spine, Inc.
CIE2-15-24-00
In Commercial Distribution
- 00813210020023 ()
- Length: 24 Millimeter
- Outer Diameter: 15 Millimeter
- Metallic spinal interbody fusion cage
The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-L is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-L is designed to be implanted bi-laterally via posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-L may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion. VariLift-L is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Wenzel Spine, Inc.
CIE2-11-24-00
In Commercial Distribution
- 00813210020009 ()
- Length: 24 Millimeter
- Outer Diameter: 11 Millimeter
- Metallic spinal interbody fusion cage
primaLOK SP 28mm Medium Boxless Implant, Sterile
The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0828-00
In Commercial Distribution
- 00813210021785 ()
- Width: 28 Millimeter
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 15mm Implant Assembly, Sterile
The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0115-00
In Commercial Distribution
- 00813210021761 ()
- Height: 15 Millimeter
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 8mm Implant Assembly, Sterile
The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0108-00
In Commercial Distribution
- 00813210021730 ()
- Height: 8 Millimeter
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-L is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-L is designed to be implanted bi-laterally via posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-L may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion. VariLift-L is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Wenzel Spine, Inc.
CIE2-13-24-00
In Commercial Distribution
- 00813210020016 ()
- Length: 24 Millimeter
- Outer Diameter: 13 Millimeter
- Metallic spinal interbody fusion cage
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution
- 08625630003034 ()
203511 SD
- Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution
- 08625630003027 ()
- Length: 30 Millimeter
- Length: 35 Millimeter
- Length: 40 Millimeter
- Length: 45 Millimeter
- Length: 50 Millimeter
- Length: 55 Millimeter
- Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511
- Intraurethral valve/pump
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution
- 08625630003010 ()
403507
- Intraurethral valve/pump
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution
- 08625630003003 ()
203511 SD
- Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution
- 08625630003002 ()
- Length: 60 Millimeter
- Length: 55 Millimeter
- Length: 50 Millimeter
- Length: 45 Millimeter
- Length: 40 Millimeter
- Length: 35 Millimeter
- Length: 30 Millimeter
203511
- Intraurethral valve/pump
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution
- 08625630003001 ()
403507
- Intraurethral valve/pump
Magnetic shield for the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution
- 00862563003191 ()
403350
- Intraurethral valve/pump
Magnetic remote control for the inFlow Device
- with base station and medical charger
VESIFLO INC
August 2021
In Commercial Distribution
- 00862563003184 ()
403507K
- Intraurethral valve/pump
Recharger for inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution
- 00862563003177 ()
403320
- Intraurethral valve/pump