FDA.reportPublic FDA data

4WEB Medical

Primary DI
00812998039012
Brand
4WEB Medical
Company
4web Medical
Model
CSTS-SA-SM0006-SP
Catalog number
CSTS-SA-SM0006-SP
Published
2019-10-11
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
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812998039012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812998039012008129980390128129980390120812998039012

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
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
00810204090017Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090024Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090031Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090048Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090055Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090062Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090079Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090086Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090093Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090109Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090116Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090123Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090130Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090147Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090154Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090161Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090178Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090185Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090192Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810017916108SABER-XA, Expandable Spacer, 34x26mm, 11mm, (6°)ELEVATION SPINE, INC.OVE2026-09-29
00810017916115SABER-XA, Expandable Spacer, 34x26mm, 13mm, (12°)ELEVATION SPINE, INC.OVE2026-09-29
00810017916122SABER-XA, Expandable Spacer, 34x26mm, 16mm, (18°)ELEVATION SPINE, INC.OVE2026-09-29
00810017916177SABER-XA, Expandable Spacer, 37x28mm,11mm, (6°)ELEVATION SPINE, INC.OVE2026-09-29
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.OVE2026-09-22
10888857026551CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2022-06-06
10888857026582CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2022-06-06