FDA.reportPublic FDA data

VariLift-LX

Primary DI
00813210020351
Brand
VariLift-LX
Company
Wenzel Spine, Inc.
Model
CIE2-A014
Device description
Reducer, Hurricane Handle
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151900000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151900000VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.2015-12-11MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813210020351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813210020351008132100203518132100203510813210020351

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument dismantling deviceA device designed to dismantle (take apart) the component parts of an implant or a surgical instrument that have previously been assembled. It may be used as a stand-alone device or in combination with another device to control the dismantling process of, e.g., complex implants (e.g., a modular vertebral implant that has to be dismantled if the combination of the component parts do not fit the required size) or instruments so that these are correctly disassembled, without causing damage to any of the parts. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
855-936-9351info@wenzelspine.com

Regulatory Flags#

DUNS number
832543255
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813210020726VariLift-LXCIE2-A012-C012025-09-23
00813210020733VariLift-LXCIE2-A013-C012025-09-23
00813210020009VariLift-LCIE2-11-24-002015-12-17
00813210020016VariLift-LCIE2-13-24-002015-12-17
00813210020023VariLift-LCIE2-15-24-002015-12-17
00813210020030VariLift-CCIC1-7.5-12-BP2015-12-17
00813210020047VariLift-CCIC1-9.0-12-BP2015-12-17
00813210020054VariLift-CCIC1-7.5-12-002016-05-16
00813210020061VariLift-CCIC1-9.0-12-002016-05-16
00813210020078VariLift-LXCIE3-11-24-002016-02-18
00813210020085VariLift-LXCIE3-13-24-002016-02-18
00813210020092VariLift-LXCIE3-12-24-002016-02-18
00813210020108VariLift-LXCIE3-14-24-002016-02-18
00813210020115VariLift-LXCIE3-15-24-002016-02-18
00813210020122VariLift-LXCIE3-10-28-002016-02-18
00813210020139VariLift-LXCIE3-11-28-002016-02-18
00813210020146VariLift-LXCIE3-12-28-002016-02-18
00813210020153VariLift-LXCIE3-13-28-002016-02-18
00813210020160VariLift-LXCIE3-14-28-002016-02-18
00813210020177VariLift-LXCIE3-15-28-002016-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606185110LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185127LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185134LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
04546540665720AVS NAVIGATORStryker CorporationMAX2016-09-24
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046226AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046288AVS PLStryker CorporationMAX2015-09-14
07613153046295AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046318AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046349AVS PLStryker CorporationMAX2015-09-14