FDA.reportPublic FDA data

4WEB Medical

Primary DI
00812998027422
Brand
4WEB Medical
Company
4web Medical
Model
TSTS-MD0615-40-SP
Catalog number
TSTS-MD0615-40-SP
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812998027422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812998027422008129980274228129980274220812998027422

GMDN Terms#

Term, Definition table
TermDefinition
Metallic 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 metal [e.g., titanium (Ti)] 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021323706
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008129980540084WEB MedicalATS-020000-05ATS-020000-052024-11-22
008129980540154WEB MedicalATS-020000-06ATS-020000-062024-11-22
008129980540224WEB MedicalATS-020000-07ATS-020000-072024-11-22
008129980540394WEB MedicalATS-020000-08ATS-020000-082024-11-22
008129980540464WEB MedicalATS-020000-09ATS-020000-092024-11-22
008129980540534WEB MedicalATS-020000-10ATS-020000-102024-11-22
008129980544284WEB MedicalATS-020000-01ATS-020000-012024-11-22
008100747560134WEB Medical4WEB-0000074WEB-0000072023-02-09
008129980522574WEB MedicalCSTS2-MD1206-SPCSTS2-MD1206-SP2026-04-28
008129980568284WEB MedicalLSTS-SM0608-MS2LSTS-SM0608-MS22026-04-07
008129980568354WEB MedicalLSTS-SM0610-MS2LSTS-SM0610-MS22026-04-07
008129980568424WEB MedicalLSTS-SM0612-MS2LSTS-SM0612-MS22026-04-07
008129980568594WEB MedicalLSTS-SM1208-MS2LSTS-SM1208-MS22026-04-07
008129980568664WEB MedicalLSTS-SM1210-MS2LSTS-SM1210-MS22026-04-07
008129980568734WEB MedicalLSTS-SM1212-MS2LSTS-SM1212-MS22026-04-07
008129980568804WEB MedicalLSTS-MD0608-MS2LSTS-MD0608-MS22026-04-07
008129980568974WEB MedicalLSTS-MD0610-MS2LSTS-MD0610-MS22026-04-07
008129980569034WEB MedicalLSTS-MD0612-MS2LSTS-MD0612-MS22026-04-07
008129980569104WEB MedicalLSTS-MD1208-MS2LSTS-MD1208-MS22026-04-07
008129980569274WEB MedicalLSTS-MD1210-MS2LSTS-MD1210-MS22026-04-07

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