FDA.reportPublic FDA data

Trabis®

Primary DI
07640173166818
Brand
Trabis®
Company
coLigne AG
Model
015.030.351
Device description
domed cage
Published
2018-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLRSpinal Vertebral Body Replacement Device - Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLRSpinal Vertebral Body Replacement Device - CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173893000TrabisColigne AG2018-09-06PLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640173166818PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640173166818076401731668187640173166818

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric 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 non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+41433438000info@coligne.com

Regulatory Flags#

DUNS number
482467792
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640173165170GII83.5302021-07-01
07640173165187GII83.5352021-07-01
07640173165194GII83.5402021-07-01
07640173165200GII83.5452021-07-01
07640173165217GII83.5502021-07-01
07640173165224GII83.5552021-07-01
07640173165231GII83.6302021-07-01
07640173165248GII83.6352021-07-01
07640173165255GII83.6402021-07-01
07640173165262GII83.6452021-07-01
07640173165279GII83.6502021-07-01
07640173165286GII83.6552021-07-01
07640173165293GII83.6602021-07-01
07640173165309GII83.7352021-07-01
07640173165316GII83.7402021-07-01
07640173165323GII83.7452021-07-01
07640173165330GII83.7502021-07-01
07640173165347GII83.7552021-07-01
07640173165354GII83.7602021-07-01
07640173165361GII83.7702021-07-01

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Primary DI, Brand, Company table
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10888857023819SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
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10888857023833SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023840SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
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10888857023864SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
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10888857023314SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
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10888857023567SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857023673SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857023680SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857023697SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857023703SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857023710SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857023727SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857160460CASCADIA™ Interbody SystemVB Spine LLCPLR2018-04-16