TETRIS R ST 12°
- Primary DI
- 04047844115596
- Brand
- TETRIS R ST 12°
- Company
- SIGNUS Medizintechnik GmbH
- Model
- Lumbar cage, angled
- Catalog number
- TRT12170928
- Device description
- The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
- Published
- 2025-02-03
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04047844115596 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04047844115596 | 04047844115596 | 4047844115596 |
GMDN Terms
| Term | Definition |
|---|
| Metallic spinal interbody fusion cage | A 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 |
|---|
| Device Size Text, specify | 0 | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 0 Degrees Celsius | 35 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| +49602391660 | info@signus.com |
Regulatory Flags
- DUNS number
- 344203948
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
| 04047844129272 | INSTRUMENT | Tray, instruments | P009AY | 2026-02-11 |
| 04047844129289 | INSTRUMENT | Tray, insert, instruments | P009AZ | 2026-02-11 |
| 04047844129296 | COSY | Tray, implants | CA01AY | 2026-02-11 |
| 04047844129302 | COSY | Tray, insert, implants | CA01AZ | 2026-02-11 |
| 04047844129319 | COSY | Tray, implants | CA02AY | 2026-02-11 |
| 04047844129326 | COSY | Rack, screws | CA1235AZ | 2026-02-11 |
| 04047844129333 | COSY | Rack, screws | CA1240AZ | 2026-02-11 |
| 04047844129340 | COSY | Rack, screws | CA1245AZ | 2026-02-11 |
| 04047844129357 | COSY | Rack, shank screws | CA1735AZ | 2026-02-11 |
| 04047844129364 | COSY | Rack, shank screws | CA1740AZ | 2026-02-11 |
| 04047844129371 | COSY | Rack, screws angled | CA3235AZ | 2026-02-11 |
| 04047844129388 | COSY | Rack, screws angled | CA3240AZ | 2026-02-11 |
| 04047844129395 | COSY | Rack, set screws | CA0140AZ | 2026-02-11 |
| 04047844129401 | COSY | Rack, set screws, connectors | CA0150AZ | 2026-02-11 |
| 04047844130124 | INSTRUMENT | Lamina Spreader | SN0027 | 2026-01-19 |
| 04047844122860 | CYLOX ST 12° | Cervical cage integrated, stand alone, angled | CYS12061512 | 2025-09-11 |
| 04047844122877 | CYLOX ST 12° | Cervical cage integrated, stand alone, angled | CYS12071512 | 2025-09-11 |
| 04047844122884 | CYLOX ST 12° | Cervical cage integrated, stand alone, angled | CYS12081512 | 2025-09-11 |
| 04047844122891 | CYLOX ST 12° | Cervical cage integrated, stand alone, angled | CYS12091512 | 2025-09-11 |
| 04047844122907 | CYLOX ST 12° | Cervical cage integrated, stand alone, angled | CYS12101512 | 2025-09-11 |
Other Devices Sharing Product Codes
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