FDA.reportPublic FDA data

L-Varlock

Primary DI
03700406328032
Brand
L-Varlock
Company
KISCO INTERNATIONAL
Model
Lumbar posterior cage W10 H13
Catalog number
VAL-CA-10-13
Device description
The L-Varlock is a lumbar cage, for intervertebral body fusion.
Published
2015-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

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
K080537000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080537000L-VARLOCKKiscomedica S.A.2008-06-30MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700406328032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700406328032037004063280323700406328032

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal fusion cage, non-sterileA non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
393107719
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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03700406301769OdalysPolyaxial spondylolisthesis screw Ø7 L55ODSS557552015-11-02
03700406302612OdalysPolyaxial screw Ø7 L55ODPS557552015-11-02
03700406302629OdalysPolyaxial screw Ø5 L55ODPS555552015-11-02
03700406302636OdalysPolyaxial screw Ø6 L55ODPS556552015-11-02
03700406302643OdalysPolyaxial screw Ø5 L45ODPS555452015-11-02
03700406302650OdalysPolyaxial screw Ø5 L50ODPS555502015-11-02
03700406320678OdalysPolyaxial spondylolisthesis screw Ø5 L55ODSS555552015-11-02
03700406334408OdalysLocking capODLS2015-11-02
03700406334828OdalysPolyaxial screw Ø5 L30ODPS555302015-11-02
03700406334835OdalysPolyaxial screw Ø5 L35ODPS555352015-11-02
03700406334842OdalysPolyaxial screw Ø5 L40ODPS555402015-11-02
03700406334866OdalysPolyaxial screw Ø6 L30ODPS556302015-11-02
03700406334873OdalysPolyaxial screw Ø6 L35ODPS556352015-11-02
03700406334880OdalysPolyaxial screw Ø6 L40ODPS556402015-11-02
03700406334897OdalysPolyaxial screw Ø6 L45ODPS556452015-11-02
03700406334903OdalysPolyaxial screw Ø6 L50ODPS556502015-11-02
03700406334927OdalysPolyaxial screw Ø7 L30ODPS557302015-11-02
03700406334934OdalysPolyaxial screw Ø7 L35ODPS557352015-11-02
03700406334941OdalysPolyaxial screw Ø7 L40ODPS557402015-11-02

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