TETRIS II 8° T28091124

GUDID 04047844011140

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

Metallic spinal interbody fusion cage
Primary Device ID04047844011140
NIH Device Record Keyf9e9c78c-6192-49cc-8da9-23e857fa7da3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTETRIS II 8°
Version Model NumberLumbar cage, angled
Catalog NumberT28091124
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

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104047844011140 [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 Number8
Public Version Date2020-02-24
Device Publish Date2015-09-24

On-Brand Devices [TETRIS II 8°]

04047844011140The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844011119The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844011096The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844011072The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844011058The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844011027The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010990The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010969The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010938The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010884The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010853The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010822The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010792The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010761The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010730The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010709The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010679The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010648The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
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