FDA.reportPublic FDA data

VariLift-L

Primary DI
00813210020757
Brand
VariLift-L
Company
Wenzel Spine, Inc.
Model
CIE2-A023-C01
Device description
13-15mm Extended Inserter
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813210020757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813210020757008132100207578132100207570813210020757

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
Premarket exempt
true
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
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00843511102340Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
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00843511102364Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102371Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102388Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102395Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102401Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102418Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102425Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22