MONOPOLY
- Primary DI
- 04047844005118
- Brand
- MONOPOLY
- Company
- SIGNUS Medizintechnik GmbH
- Model
- Pedicle screw, reduction, monoaxial
- Catalog number
- MP0130-8535
- Device description
- The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti-6AL-4V-Eli).
- Published
- 2014-08-31
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04047844005118 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04047844005118 | 04047844005118 | 4047844005118 |
GMDN Terms
| Term | Definition |
|---|
| Bone-screw internal spinal fixation system, non-sterile | An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included. |
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 | |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 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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