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Wenzel Spine

Matched from indexed company URL: WENZEL SPINE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30061725363006172536Wenzel Spine1N2026-01-012535 Brockton Dr Ste 450 Austin TX US 78758
30080098503008009850WENZEL SPINE, Inc.1N2020-04-251130 Rutherford Lane Suite 200 Austin TX US 78753

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00813210020153VariLift-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.855-936-9351info@wenzelspine.com
00813210020160VariLift-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.855-936-9351info@wenzelspine.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2830211918368509K250247panaSIa SI Fusion SystemOUR2025-07-09
2830211214771052K231807primaLOK™ SP Interspinous Fusion SystemPEK2023-08-15
2830211383594176K231076VariLift®-C Interbody Fusion SystemODP2023-09-27
2830211351739311K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemMAX2019-01-28
2830211670855334K173247Surgical Planning Software version 1.1LLZ2017-11-08
2830211515090828K172327VMA™ System version 3.0LLZ2017-08-25
1100241146917381K151900VariLift-L Interbody Fusion DeviceMAX2015-12-11
1100241520775765K131296VARILIFT-L INTERBODY FUSION DEVICEMAX2013-09-03
1100241452407044K120603VARILIFT -CODP2013-01-29
1100241361512159K111123VARILIFT CERVICAL INTERBODY FUSION SYSTEMODP2011-12-08
1100241983676833K102438PRIMALOK FACET FIXATION SYSTEMMRW2010-09-30
2830211983676833K102438PRIMALOK FACET FIXATION SYSTEMMRW2010-09-30
2830211305169931K100820WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEMMAX2010-08-05
1100241305169931K100820WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEMMAX2010-08-05
1100241613069402K100354PRIMAL OK INTERSPINOUS FUSION SYSTEMKWP2010-08-17
2830211613069402K100354PRIMAL OK INTERSPINOUS FUSION SYSTEMKWP2010-08-17
1100242045541059K030608OTI BONE CEMENT PLUGJDK2003-06-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX52019-01-28
ODP32023-09-27
LLZ22017-11-08
MRW22010-09-30
KWP22010-08-17
OUR12025-07-09
PEK12023-08-15
JDK12003-06-12

PMN#

GUDID#

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.

Wenzel Spine, Inc.

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.

Wenzel Spine, Inc.

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.

Wenzel Spine, Inc.

2017-08-07

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.

Wenzel Spine, Inc.

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.

Wenzel Spine, Inc.

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.

Wenzel Spine, Inc.

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.

Wenzel Spine, Inc.

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.

Wenzel Spine, Inc.

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.

Wenzel Spine, Inc.

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.

Wenzel Spine, Inc.

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.

Wenzel Spine, Inc.

2015-12-17

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