FDA.reportPublic FDA data

PLIF Cage

Primary DI
B52310035718270914
Brand
PLIF Cage
Company
Eisertech, LLC
Model
100357-18-270914
Catalog number
100357-18-270914
Device description
Lordotic TPLIF Cage, Titanium 27AP X 09ML X 14HT, 18 Deg
Published
2018-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K113478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113478000PLIF CAGEEisertech, LLC2012-03-05MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B52310035718270914PrimaryHIBCC0

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
965627297
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B5231003204525Pedicle Screw100320-4525D100320-4525D2019-08-19
B5231003204530Pedicle Screw100320-4530D100320-4530D2019-08-19
B5231003204555Pedicle Screw100320-4555D100320-4555D2019-08-19
B5231003204560Pedicle Screw100320-4560D100320-4560D2019-08-19
B5231003205525Pedicle Screw100320-5525D100320-5525D2019-08-19
B5231003206525Pedicle Screw100320-6525D100320-6525D2019-08-19
B5231003206565Pedicle Screw100320-6565D100320-6565D2019-08-19
B5231003206570Pedicle Screw100320-6570D100320-6570D2019-08-19
B5231003207525Pedicle Screw100320-7525D100320-7525D2019-08-19
B5231003207565Pedicle Screw100320-7565D100320-7565D2019-08-19
B5231003207570Pedicle Screw100320-7570D100320-7570D2019-08-19
B5231003207575Pedicle Screw100320-7575D100320-7575D2019-08-19
B5231003207580Pedicle Screw100320-7580D100320-7580D2019-08-19
B5231003208570Pedicle Screw100320-8570D100320-8570D2019-08-19
B5231003208580Pedicle Screw100320-8580D100320-8580D2019-08-19
B5231003208590Pedicle Screw100320-8590D100320-8590D2019-08-19
B5231000024530Pedicle Screw100002-4530C100002-4530C2018-04-09
B5231000025025Pedicle Screw100002-5025C100002-5025C2018-04-09
B5231000025030Pedicle Screw100002-5030C100002-5030C2018-04-09
B5231000025035Pedicle Screw100002-5035C100002-5035C2018-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043912870N/ATDM Co., Ltd.MAX2026-06-02
08800043912887N/ATDM Co., Ltd.MAX2026-06-02
08800043912894N/ATDM Co., Ltd.MAX2026-06-02
08800043912900N/ATDM Co., Ltd.MAX2026-06-02
08800043912917N/ATDM Co., Ltd.MAX2026-06-02
08800043912924N/ATDM Co., Ltd.MAX2026-06-02
08800043912931N/ATDM Co., Ltd.MAX2026-06-02
08800043912948N/ATDM Co., Ltd.MAX2026-06-02
08800043912955N/ATDM Co., Ltd.MAX2026-06-02
08800043912962N/ATDM Co., Ltd.MAX2026-06-02
08800043912979N/ATDM Co., Ltd.MAX2026-06-02
08800043912986N/ATDM Co., Ltd.MAX2026-06-02
08800043912993N/ATDM Co., Ltd.MAX2026-06-02
08800043913006N/ATDM Co., Ltd.MAX2026-06-02
08800043913013N/ATDM Co., Ltd.MAX2026-06-02
08800043913020N/ATDM Co., Ltd.MAX2026-06-02
08800043913037N/ATDM Co., Ltd.MAX2026-06-02
08800043913044N/ATDM Co., Ltd.MAX2026-06-02
08800043913051N/ATDM Co., Ltd.MAX2026-06-02
08800043913068N/ATDM Co., Ltd.MAX2026-06-02
08800043913075N/ATDM Co., Ltd.MAX2026-06-02
08800043964183N/ATDM Co., Ltd.MAX2026-06-02
08800043964190N/ATDM Co., Ltd.MAX2026-06-02
08800043964206N/ATDM Co., Ltd.MAX2026-06-02
08800043964213N/ATDM Co., Ltd.MAX2026-06-02
08800043964220N/ATDM Co., Ltd.MAX2026-06-02
08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02
08800043964268N/ATDM Co., Ltd.MAX2026-06-02