TETRIS II 0° T2K0061124

GUDID 04047844010624

The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered leading face. 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 avaiable in a variety of sizes and angulations thereby enabling the surgeon to choose the size best united to the individual pathology and anatomical condition.

SIGNUS Medizintechnik GmbH

Polymeric spinal fusion cage, sterile
Primary Device ID04047844010624
NIH Device Record Keyc9b0f34f-1adf-4fd2-b952-1e867f49e8c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTETRIS II 0°
Version Model NumberLumbar cage, straight
Catalog NumberT2K0061124
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
Phone+49602391660
Emailinfo@signus.com

Device Dimensions

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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
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104047844010624 [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 II 0°]

04047844011157The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844011126The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844011034The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844011003The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010976The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010914The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010907The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010891The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010860The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010839The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010808The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010778The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010747The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010716The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010686The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010655The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010624The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010945The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l

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