FDA.reportPublic FDA data

TETRIS 4°

Primary DI
04047844023402
Brand
TETRIS 4°
Company
SIGNUS Medizintechnik GmbH
Model
Lumbar cage, angled
Catalog number
T43811
Device description
The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™devices is a hollow structural 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 available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MQPSpinal Vertebral Body Replacement Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111792000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111792000MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINISignus Medizintechnik GmbH2012-03-05MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04047844023402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04047844023402040478440234024047844023402

GMDN Terms#

Term, Definition table
TermDefinition
Metallic 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 metal [e.g., titanium (Ti)] 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49602391660info@signus.com

Regulatory Flags#

DUNS number
344203948
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04047844129418DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-951202026-07-13
04047844129425DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450252026-07-13
04047844129432DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450302026-07-13
04047844129449DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450352026-07-13
04047844129456DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450402026-07-13
04047844129463DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450452026-07-13
04047844129470DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450502026-07-13
04047844129487DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450552026-07-13
04047844129494DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450602026-07-13
04047844129500DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550252026-07-13
04047844129517DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550302026-07-13
04047844129524DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550352026-07-13
04047844129531DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550402026-07-13
04047844129548DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550452026-07-13
04047844129555DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550502026-07-13
04047844129562DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550552026-07-13
04047844129579DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550602026-07-13
04047844129586DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-650252026-07-13
04047844129593DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-650302026-07-13
04047844129609DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-650352026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M719GLL100QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
M719GLL101QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
M719GLL106QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
M719GLL107QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
00763000857820T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-26
00763000858001T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-26
08800043913099N/ATDM Co., Ltd.MAX2026-06-10
08800043913105N/ATDM Co., Ltd.MAX2026-06-10
08800043913112N/ATDM Co., Ltd.MAX2026-06-10
08800043913129N/ATDM Co., Ltd.MAX2026-06-10
08800043913136N/ATDM Co., Ltd.MAX2026-06-10
08800043913143N/ATDM Co., Ltd.MAX2026-06-10
08800043913150N/ATDM Co., Ltd.MAX2026-06-10
08800043913167N/ATDM Co., Ltd.MAX2026-06-10
08800043913174N/ATDM Co., Ltd.MAX2026-06-10
08800043913181N/ATDM Co., Ltd.MAX2026-06-10
08800043913198N/ATDM Co., Ltd.MAX2026-06-10
08800043913204N/ATDM Co., Ltd.MAX2026-06-10
08800043913211N/ATDM Co., Ltd.MAX2026-06-10
08800043917288N/ATDM Co., Ltd.MAX2026-06-10
08800043917295N/ATDM Co., Ltd.MAX2026-06-10
08800043917301N/ATDM Co., Ltd.MAX2026-06-10
08800043917318N/ATDM Co., Ltd.MAX2026-06-10
08800043917325N/ATDM Co., Ltd.MAX2026-06-10
08800043917332N/ATDM Co., Ltd.MAX2026-06-10
08800043917349N/ATDM Co., Ltd.MAX2026-06-10
08800043967177N/ATDM Co., Ltd.MAX2026-06-10
08800043967184N/ATDM Co., Ltd.MAX2026-06-10
08800043967191N/ATDM Co., Ltd.MAX2026-06-10
08800043967207N/ATDM Co., Ltd.MAX2026-06-10