FDA.reportPublic FDA data

4WEB Medical

Primary DI
00812998053858
Brand
4WEB Medical
Company
4web Medical
Model
CSTS-000041
Catalog number
CSTS-000041
Published
2024-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812998053858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812998053858008129980538588129980538580812998053858

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
021323706
Device count
1
Lot or batch
true
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
008129980264564WEB MedicalASTS-LG1210-LPASTS-LG1210-LP2018-12-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.OVE2026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.ODP2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCODP2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19