FDA UDI
In Commercial Distribution
🇺🇸 United States
TETRIS 0°
DI: 04047844018439
·
Model: Lumbar cage, straight
·
SIGNUS Medizintechnik GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TETRIS 0°
- Primary DI
- 04047844018439
- Version / Model
- Lumbar cage, straight
- Catalog Number
- TK141120
- Company Name
- SIGNUS Medizintechnik GmbH
- Labeler DUNS
- 344203948
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 8
- Public Version Date
- 2023-09-22
- Public Version Status
- Update
- Public Device Record Key
- 2f22e09d-e28d-4852-83f0-9fc55926bfb1
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | 888.3060 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60762 | Polymeric 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 non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04047844018439 | GS1 |
Customer Contacts
- Phone
- +49602391660
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111792 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 14x11x20mm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 35 Degrees Celsius