FDA.reportPublic FDA data

Tritanium C

Primary DI
07613327347197
Brand
Tritanium C
Company
Stryker Corporation
Model
48982076
Catalog number
48982076
Device description
Anterior Cervical Cage
Published
2017-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327347197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327347197076133273471977613327347197

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0
Height0
Length0
Width0

Regulatory Flags#

DUNS number
149183167
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327524475Optablate97000151009700-015-1002022-09-23
07613327638233Omnicurve10320150001032-015-0002024-09-03
00857037006075LATERALATSYS24LATSYS242020-01-14
00857037006037LATERALATSYS20LATSYS202020-01-08
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327006223ARIA48755700487557002019-11-20
07613327006919ES2 SPINAL SYSTEM48280082482800822019-11-20
07613327006926ES2 SPINAL SYSTEM48280083482800832019-11-20
07613327006940ES2 SPINAL SYSTEM48280086482800862019-11-20
07613327006957ES2 SPINAL SYSTEM48280087482800872019-11-20
07613327007114ES2 SPINAL SYSTEM48280311482803112019-11-25
07613327007558XIA 348237078482370782019-11-25
07613327007565XIA 348237079482370792019-11-25
07613327067088ACCULIF8003578003572016-09-24
07613327067095ACCULIF8003478003472016-09-24
07613327114799XIA 4.5 EVOLUTION48138140481381402019-11-21
07613327114812XIA 4.5 EVOLUTION48138011R48138011R2019-11-20
07613327114843XIA 4.5 EVOLUTION48138011L48138011L2019-11-20
07613327114850XIA 4.5 EVOLUTION48138101481381012019-11-21
07613327114874ES2 SPINAL SYSTEM48280178482801782019-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.ODP2026-09-22
07613327503968Aero-CStryker CorporationODP2019-12-18
10888857461819CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
07613327353921Aero-CStryker CorporationODP2018-06-28
07613327353938Aero-CStryker CorporationODP2018-06-28
07613327353945Aero-CStryker CorporationODP2018-06-28
07613327353952Aero-CStryker CorporationODP2018-06-28
07613327353976Aero-CStryker CorporationODP2018-06-28
07613327347036Tritanium CStryker CorporationODP2017-09-18
07613327347050Tritanium CStryker CorporationODP2017-09-18
07613327347067Tritanium CStryker CorporationODP2017-09-18
07613327347098Tritanium CStryker CorporationODP2017-09-18
07613327347159Tritanium CStryker CorporationODP2017-09-18
07613327347296Tritanium CStryker CorporationODP2017-09-18
07613327347333Tritanium CStryker CorporationODP2017-09-18
07613327347357Tritanium CStryker CorporationODP2017-09-18
07613327347364Tritanium CStryker CorporationODP2017-09-18
07613327349535Tritanium CStryker CorporationODP2017-09-18
07613327360035Tritanium CStryker CorporationODP2017-09-18
07613327360103Tritanium CStryker CorporationODP2017-09-18
07613327360257Tritanium CStryker CorporationODP2017-09-18
07613327360363Tritanium CStryker CorporationODP2017-09-18
07613327360370Tritanium CStryker CorporationODP2017-09-18
07613327360516Tritanium CStryker CorporationODP2017-09-18
07613252602774AVS Anchor-LStryker CorporationODP2016-09-24
07613252602781AVS Anchor-LStryker CorporationODP2016-09-24