FDA.report

4WEB Medical

Primary DI
00810074758246
Brand
4WEB Medical
Company
4web Medical
Model
CSTS2-SM07010-SP
Catalog number
CSTS2-SM0710-SP
Published
2023-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications

CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810074758246PrimaryGS10

GMDN Terms

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

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
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
008129980527904WEB Medical4WEB-OA51S-SLV2054WEB-OA51S-SLV2052026-01-22
000812998052794WEB Medical4WEB-OA51S-SLV2054WEB-OA51S-SLV2052026-01-22
008129980526844WEB Medical4WEB-OA51S-LV1254WEB-OA51S-LV1252026-01-22
008129980527144WEB Medical4WEB-OA51S-LV2054WEB-OA51S-LV2052026-01-22
008129980527214WEB Medical4WEB-OA51S-SV1254WEB-OA51S-SV1252026-01-22
008129980527524WEB Medical4WEB-OA51S-SV2054WEB-OA51S-SV2052026-01-22
008129980527694WEB Medical4WEB-OA51S-SLV1254WEB-OA51S-SLV1252026-01-22
008129980528064WEB Medical4WEB-OA51S-SSV1254WEB-OA51S-SSV1252026-01-22
008129980528204WEB Medical4WEB-OA51S-SSV2054WEB-OA51S-SSV2052026-01-22
008129980528444WEB Medical4WEB-OA51S-P1254WEB-OA51S-P1252026-01-22
008129980528754WEB Medical4WEB-OA51S-P2054WEB-OA51S-P2052026-01-22
008129980556924WEB Medical4WEB-LAS-BLD-SS0904WEB-LAS-BLD-SS0902026-01-22
008129980557084WEB Medical4WEB-LAS-BLD-SS1004WEB-LAS-BLD-SS1002026-01-22
008129980557154WEB Medical4WEB-LAS-BLD-SS1104WEB-LAS-BLD-SS1102026-01-22
008129980557224WEB Medical4WEB-LAS-BLD-SS1204WEB-LAS-BLD-SS1202026-01-22
008129980557394WEB Medical4WEB-LAS-BLD-SS1304WEB-LAS-BLD-SS1302026-01-22
008129980557464WEB Medical4WEB-LAS-BLD-SS1404WEB-LAS-BLD-SS1402026-01-22
008129980557534WEB Medical4WEB-LAS-BLD-SS1504WEB-LAS-BLD-SS1502026-01-22
008129980557604WEB Medical4WEB-LAS-BLD-SS1604WEB-LAS-BLD-SS1602026-01-22
008129980526464WEB Medical4WEB-OA51S-H1254WEB-OA51S-H1252026-01-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840283404245ClariVy™VY SPINE LLCODP2026-03-19
00840283404252ClariVy™VY SPINE LLCODP2026-03-19
00840283404269ClariVy™VY SPINE LLCODP2026-03-19
00840283404276ClariVy™VY SPINE LLCODP2026-03-19
00840283404283ClariVy™VY SPINE LLCODP2026-03-19
00840493416687LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00840493416694LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00840493416700LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00841193127521EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127538EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127545EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127552EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127569EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127576EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127583EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127590EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127606EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127613EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127620EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127637EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127644EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127651EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127668EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127675EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
10195860030421E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030438E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030445E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030452E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030506E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030537E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20