TETRIS 4° TK40711

GUDID 04047844001172

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 ID04047844001172
NIH Device Record Keybfd2557c-bd09-41ac-80ce-1d75a8e757bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameTETRIS 4°
Version Model NumberLumbar cage, angled
Catalog NumberTK40711
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
GS104047844001172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-10-24
Device Publish Date2015-09-24

On-Brand Devices [TETRIS 4°]

04047844019184The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844019160The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844019153The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844019146The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844019139The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844001066The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844001059The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844001042The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844001035The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844001028The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844001011The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844019214The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844019207The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844019191The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844018378The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844018361The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844010525The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001530The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001523The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001516The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001509The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001493The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001486The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001240The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001233The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001226The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001219The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001202The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001196The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001189The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001172The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844001165The basic shape of the KIMBA, KIMBA mini, MOBIS, NOVAL, PEEK TETRIS and Titanium TETRIS devices
04047844023600The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023594The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023556The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023549The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023532The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023525The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023518The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023501The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023495The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023488The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023471The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023464The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023457The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023440The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023433The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023426The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023419The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti
04047844023402The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Ti

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.