FDA.reportPublic FDA data

TETRIS 0°

Primary DI
04047844001301
Brand
TETRIS 0°
Company
SIGNUS Medizintechnik GmbH
Model
Lumbar cage, straight
Catalog number
TK060924
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
K123758000

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
K123758000TASMIN RSignus Medizintechnik GmbH2014-01-14MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04047844001301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04047844001301040478440013014047844001301

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
04047844130957DIPLOMATGuide wire, round/roundAC01602026-10-26
04047844130964DIPLOMATGuide wire, trocar/roundAC01612026-10-26
04047844005668KAINOS+Bone graft substitute, granules 2-3mmK001NT2015-09-24
04047844005675KAINOS+Bone graft substitute, granules 2-3mmK003NT2015-09-24
04047844005682KAINOS+Bone graft substitute, granules 2-3mmK004NT2015-09-24
04047844005699KAINOS+Bone graft substitute, granules 2-3mmK005NT2015-09-24
04047844005705KAINOS+Bone graft substitute, granules 2-3mmK006NT2015-09-24
04047844005712KAINOS+Bone graft substitute, insert for NUBICKNB0413142018-09-20
04047844005729KAINOS+Bone graft substitute, insert for NUBICKNB0513142018-09-20
04047844005736KAINOS+Bone graft substitute, insert for NUBICKNB0613142018-09-20
04047844005743KAINOS+Bone graft substitute, insert for NUBICKNB0713142018-09-20
04047844005750KAINOS+Bone graft substitute, insert for NUBICKNB0813142018-09-20
04047844005996KAINOS+Bone graft substitute, granules 1-2mmKS03NT2015-09-24
04047844006009KAINOS+Bone graft substitute, granules 1-2mmKS06NT2015-09-24
04047844023747KAINOS+Bone graft substitute, granulate 2-3mmK002NT2015-09-24
04047844130971DIPLOMATGuide wire, round/roundAC01622026-08-14
04047844130988DIPLOMATGuide wire, trocar/roundAC01632026-08-14
04047844066768DIPLOMATGuide wire, trocar/roundAC01262025-05-21
04047844042779DIPLOMATGuide wire obturatorAC0003-22022-06-09
04047844066751DIPLOMATGuide wire, round/roundAC01252022-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809974858424Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858431Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858448Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858455Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858462Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858479Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858486Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858493Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858509Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858516Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858523Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858530Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858547Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858554Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858561Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858578Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858585Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858592Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858608Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858615Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858622Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858639Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858646Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858653Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858660Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858677Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858684Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858691Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858707Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858714Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19