FDA.reportPublic FDA data

4WEB Medical

Primary DI
00812998026456
Brand
4WEB Medical
Company
4web Medical
Model
ASTS-LG1210-LP
Catalog number
ASTS-LG1210-LP
Published
2018-12-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
00812998026456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812998026456008129980264568129980264560812998026456

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 typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped 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 packaged with the cage.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
021323706
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008129980366464WEB MedicalASTS-MD1216-LPASTS-MD1216-LP2020-07-17
008129980366534WEB MedicalASTS-MD1216-LPASTS-MD1216-LP2020-07-17
008129980264634WEB MedicalASTS-LG1212-LPASTS-LG1212-LP2018-12-14
008129980264874WEB MedicalASTS-LG0610-LPASTS-LG0610-LP2018-12-14
008129980264944WEB MedicalASTS-LG0612-LPASTS-LG0612-LP2018-12-14
008129980265004WEB MedicalASTS-LG0614-LPASTS-LG0614-LP2018-12-14
008129980265174WEB MedicalASTS-MD1210-LPASTS-MD1210-LP2018-12-14
008129980265244WEB MedicalASTS-MD1212-LPASTS-MD1212-LP2018-12-14
008129980265314WEB MedicalASTS-MD1214-LPASTS-MD1214-LP2018-12-14
008129980346974WEB MedicalASTS-MD1210-LP-SASTS-MD1210-LP-S2018-12-14
008129980347034WEB MedicalASTS-MD1212-LP-SASTS-MD1212-LP-S2018-12-14
008129980347104WEB MedicalASTS-MD1214-LP-SASTS-MD1214-LP-S2018-12-14
008129980347274WEB MedicalASTS-LG0610-LP-SASTS-LG0610-LP-S2018-12-14
008129980347344WEB MedicalASTS-LG0612-LP-SASTS-LG0612-LP-S2018-12-14
008129980347414WEB MedicalASTS-LG0614-LP-SASTS-LG0614-LP-S2018-12-14
008129980347584WEB MedicalASTS-LG1210-LP-SASTS-LG1210-LP-S2018-12-14
008129980347654WEB MedicalASTS-LG1212-LP-SASTS-LG1212-LP-S2018-12-14
008129980358544WEB MedicalASTS-MD1216-LP-SASTS-MD1216-LP-S2018-12-14
008129980540084WEB MedicalATS-020000-05ATS-020000-052024-11-22
008129980540154WEB MedicalATS-020000-06ATS-020000-062024-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916191SABER-XA, Expandable Spacer, 37x28mm, 16mm, (18°)ELEVATION SPINE, INC.MAX2026-10-27
08809974869284Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809885799977Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809885799984Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809885799991Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779934Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779941Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779958Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779965Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779972Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779989Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779996Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974789957Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974789964Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974789971Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974789988Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974789995Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799864Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799871Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799888Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799895Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799901Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799918Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799925Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799932Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799949Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799956Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799963Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799970Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799987Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18