wenzelspine.comVariLift®-C Interbody Fusion System
Wenzel Spine, Inc.
WENZEL SPINE, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008009850 | 3008009850 | WENZEL SPINE, Inc. | 1 | N | 2020-04-25 | 1130 Rutherford Lane Suite 200 Austin TX US 78753 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00813210020009 | VariLift-L - 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. | 855-936-9351 | info@wenzelspine.com |
| 00813210020016 | VariLift-L - 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. | 855-936-9351 | info@wenzelspine.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 110024 | 1146917381 | K151900 | VariLift-L Interbody Fusion Device | MAX | 2015-12-11 |
| 110024 | 1520775765 | K131296 | VARILIFT-L INTERBODY FUSION DEVICE | MAX | 2013-09-03 |
| 110024 | 1452407044 | K120603 | VARILIFT -C | ODP | 2013-01-29 |
| 110024 | 1361512159 | K111123 | VARILIFT CERVICAL INTERBODY FUSION SYSTEM | ODP | 2011-12-08 |
| 110024 | 1983676833 | K102438 | PRIMALOK FACET FIXATION SYSTEM | MRW | 2010-09-30 |
| 110024 | 1305169931 | K100820 | WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM | MAX | 2010-08-05 |
| 110024 | 1613069402 | K100354 | PRIMAL OK INTERSPINOUS FUSION SYSTEM | KWP | 2010-08-17 |
| 110024 | 2045541059 | K030608 | OTI BONE CEMENT PLUG | JDK | 2003-06-12 |
Product Codes Associated With Registrations#
PMN#
primaLOK? SP Interspinous Fusion System
Wenzel Spine, Inc.
VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System
Wenzel Spine, Inc.
VariLift-L Interbody Fusion Device
WENZEL SPINE, INC.
VARILIFT-L INTERBODY FUSION DEVICE
WENZEL SPINE, INC.
GUDID#
VariLift-LX - 11mm Inserter with Distal Depth Marks
2025-09-23
VariLift-LX - 13/15mm VariLift-L Inserter with Distal Depth Marks
2025-09-23
VariLift-L - 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.
2015-12-17
VariLift-L - 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.
2015-12-17
VariLift-L - 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.
2015-12-17
VariLift-C - The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interior expansion plate, and is grooved and fluted with large graft windows positioned between each of its four quadrants that provide bony contact with the endplates. VariLift-C may be used with or without supplemental fixation. VariLift-C is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six weeks of non-operative treatment prior to treatment with VariLift-C. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The VariLift-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone.
2015-12-17
VariLift-C - The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interior expansion plate, and is grooved and fluted with large graft windows positioned between each of its four quadrants that provide bony contact with the endplates. VariLift-C may be used with or without supplemental fixation. VariLift-C is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six weeks of non-operative treatment prior to treatment with VariLift-C. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The VariLift-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone.
2015-12-17
VariLift-C - The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interior expansion plate, and is grooved and fluted with large graft windows positioned between each of its four quadrants that provide bony contact with the endplates. VariLift-C may be used with or without supplemental fixation. VariLift-C is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six weeks of non-operative treatment prior to treatment with VariLift-C. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The VariLift-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone.
2016-05-16
VariLift-C - The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interior expansion plate, and is grooved and fluted with large graft windows positioned between each of its four quadrants that provide bony contact with the endplates. VariLift-C may be used with or without supplemental fixation. VariLift-C is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six weeks of non-operative treatment prior to treatment with VariLift-C. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The VariLift-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone.
2016-05-16
VariLift-LX - The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-LX is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-LX is designed to be implanted bi-laterally via a PLIF or TLIF approach, and may be implanted with or without supplemental fixation.
2016-02-18
VariLift-LX - The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-LX is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-LX is designed to be implanted bi-laterally via a PLIF or TLIF approach, and may be implanted with or without supplemental fixation.
2016-02-18
VariLift-LX - The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-LX is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-LX is designed to be implanted bi-laterally via a PLIF or TLIF approach, and may be implanted with or without supplemental fixation.
2016-02-18
VariLift-LX - 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 The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-LX is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-LX is designed to be implanted bi-laterally via a PLIF or TLIF approach, and may be implanted with or without supplemental fixation.
2016-02-18
VariLift-LX - The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-LX is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-LX is designed to be implanted bi-laterally via a PLIF or TLIF approach, and may be implanted with or without supplemental fixation.
2016-02-18
VariLift-LX - The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-LX is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-LX is designed to be implanted bi-laterally via a PLIF or TLIF approach, and may be implanted with or without supplemental fixation.
2016-02-18
VariLift-LX - The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-LX is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-LX is designed to be implanted bi-laterally via a PLIF or TLIF approach, and may be implanted with or without supplemental fixation.
2016-02-18
VariLift-LX - The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-LX is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-LX is designed to be implanted bi-laterally via a PLIF or TLIF approach, and may be implanted with or without supplemental fixation.
2016-02-18
VariLift-LX - The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-LX is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-LX is designed to be implanted bi-laterally via a PLIF or TLIF approach, and may be implanted with or without supplemental fixation.
2016-02-18
VariLift-LX - The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-LX is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-LX is designed to be implanted bi-laterally via a PLIF or TLIF approach, and may be implanted with or without supplemental fixation.
2016-02-18
VariLift-LX - The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-LX is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-LX is designed to be implanted bi-laterally via a PLIF or TLIF approach, and may be implanted with or without supplemental fixation.
2016-02-18
VariLift-C - The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interior expansion plate, and is grooved and fluted with large graft windows positioned between each of its four quadrants that provide bony contact with the endplates. VariLift-C may be used with or without supplemental fixation. VariLift-C is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six weeks of non-operative treatment prior to treatment with VariLift-C. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The VariLift-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone.
2017-08-07
VariLift-C - The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interior expansion plate, and is grooved and fluted with large graft windows positioned between each of its four quadrants that provide bony contact with the endplates. VariLift-C may be used with or without supplemental fixation. VariLift-C is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six weeks of non-operative treatment prior to treatment with VariLift-C. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The VariLift-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone.
2017-08-07
VariLift-C - The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interior expansion plate, and is grooved and fluted with large graft windows positioned between each of its four quadrants that provide bony contact with the endplates. VariLift-C may be used with or without supplemental fixation. VariLift-C is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six weeks of non-operative treatment prior to treatment with VariLift-C. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The VariLift-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone.
2017-08-07
VariLift-LX - 10-12mm Inserter, with Distal Depth Marks
2016-09-19
VariLift-LX - 13-15mm Inserter, with Distal Depth Marks
2016-09-19
VariLift-C - Insertion Wrench
2016-09-19
VariLift-C - Removal Screwdriver
2016-09-19
VariLift-LX - Inserter, 10mm-12mm, Hurricane Handle
2016-09-19
VariLift-LX - Inserter, 13mm-15mm, Hurricane Handle
2016-09-19
VariLift-L - 10-12mm Extended Inserter
2016-09-19
VariLift-L - 13-15mm Extended Inserter
2016-09-19
VariLift-L - Inserter, 13mm-15mm, Molded Handle
2016-09-19
VariLift-L - Inserter, 10mm-12mm, Molded Handle
2016-09-19
VariLift-C - Insertion Wrench, T-Handle
2016-09-19
VariLift-L - 10-12mm Extended Inserter
2016-09-19
VariLift-L - 13-15mm Extended Inserter
2016-09-19
VariLift-C - Inserter
2017-08-07
primaLOK FF - Removal Driver
2018-06-26
primaLOK FF - Implant Driver
2018-06-26
primaLOK FF - Threaded Implant Holder Shaft - Cannulated
2018-06-26