TETRIS 0° TK121120

GUDID 04047844001448

The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices is a hollow structual frame. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is aviable in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

SIGNUS Medizintechnik GmbH

Polymeric spinal fusion cage, sterile
Primary Device ID04047844001448
NIH Device Record Keyb7993c9d-4788-42c9-af0e-6856179e4858
Commercial Distribution StatusIn Commercial Distribution
Brand NameTETRIS 0°
Version Model NumberLumbar cage, straight
Catalog NumberTK121120
Company DUNS344203948
Company NameSIGNUS Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104047844001448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal Vertebral Body Replacement Device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-09-24
Device Publish Date2015-09-24

On-Brand Devices [TETRIS 0°]

04047844019122The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844019115The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844019108The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844019092The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844019085The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844019078The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844019061The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844019054The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844001004The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844000991The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844000984The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844000977The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844000960The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844000953The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844000946The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844000939The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844018439The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844018422The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844002315The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844002308The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844002285The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844002278The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001448The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001431The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001417The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001400The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001387The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001370The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001356The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001349The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001332The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001325The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001318The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001301The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, SEMIAL, PEEK TETRIS and Titanium TETRIS
04047844001158The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001141The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001134The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001127The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001110The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001103The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001097The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001080The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001073The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844023587The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023570The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023167The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023150The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023143The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023136The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023129The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti

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