FDA.reportPublic FDA data

InFront

Primary DI
B116004CA091
Brand
InFront
Company
INFRONT MEDICAL LLC
Model
004-CA09
Catalog number
004-CA09
Device description
CURVED TLIF CAGE, L 28mm, W 10mm, H 9mm, A 0-DEG
Published
2016-02-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
B116004CA091PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1 (888) 515-2532customerservice@infrontmedical.com

Regulatory Flags#

DUNS number
079944908
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B116004CA071InFront004-CA07004-CA072016-02-29
B116004CA081InFront004-CA08004-CA082016-02-29
B116004CA0A1InFront004-CA0A004-CA0A2016-02-29
B116004CA0B1InFront004-CA0B004-CA0B2016-02-29
B116004CA0C1InFront004-CA0C004-CA0C2016-02-29
B116004CA0D1InFront004-CA0D004-CA0D2016-02-29
B116004CA0E1InFront004-CA0E004-CA0E2016-02-29
B116004CA471InFront004-CA47004-CA472016-02-29
B116004CA481InFront004-CA48004-CA482016-02-29
B116004CA491InFront004-CA49004-CA492016-02-29
B116004CA4A1InFront004-CA4A004-CA4A2016-02-29
B116004CA4B1InFront004-CA4B004-CA4B2016-02-29
B116004CA4C1InFront004-CA4C004-CA4C2016-02-29
B116004CA4D1InFront004-CA4D004-CA4D2016-02-29
B116004CA4E1InFront004-CA4E004-CA4E2016-02-29
B116003AB071InFront003-AB07003-AB072016-06-25
B116003BB081InFront003-BB08003-BB082016-06-24
B116003BB091InFront003-BB09003-BB092016-06-24
B116003BB0A1InFront003-BB0A003-BB0A2016-06-24
B116003BB0B1InFront003-BB0B003-BB0B2016-06-24

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