FDA.report

TRANSCONTINENTAL

Primary DI
00889095220223
Brand
TRANSCONTINENTAL
Company
GLOBUS MEDICAL, INC.
Model
375.998
Device description
TransContinental Spacer, 26mm x 60mm, 10deg, 15mm
Published
2015-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889095220223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889095220223008890952202238890952202230889095220223

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.

Device Sizes

TypeValueUnit
Height15Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(610)930-1800info@globusmedical.com

Regulatory Flags

DUNS number
139105691
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
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 DIBrandModelCatalogPublished
00193982622312EXCELSIUSGPS6252.00482026-03-24
00193982622329EXCELSIUSGPS6252.00492026-03-24
00889095366631EXCELSIUS GPS6143.27022019-07-31
00889095740912EXCELSIUS GPS6143.25422018-06-27
00889095782455CREO6200.10902019-07-31
00889095782462CREO6200.10952019-07-31
00889095782479CREO6200.14002019-08-01
00889095782486CREO6200.14052019-08-01
00193982647650ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.31272026-02-10
00193982647667ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.37202026-02-10
00193982647674ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.50212026-02-10
00193982647681ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.50222026-02-10
00889095305401COALITION MIS6136.10032016-10-11
00193982534011ANTHEM1181.82022026-01-27
00193982534028ANTHEM1181.82032026-01-27
00193982534035ANTHEM1181.82042026-01-27
00193982534042ANTHEM1181.82052026-01-27
00193982534059ANTHEM1181.82062026-01-27
00193982534066ANTHEM1181.82072026-01-27
00193982534073ANTHEM1181.82082026-01-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800322740446Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740453Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740460Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740477Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740484Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740491Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740507Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740514Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740521Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740538Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740545Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740552Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740569Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740576Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740583Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740590Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740606Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740613Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740620Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740637Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740644Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740651Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740668Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740675Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740682Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740699Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740705Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740712Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740729Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740736Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23