Zenius Spinal System
- Primary DI
- 08809547361276
- Brand
- Zenius Spinal System
- Company
- Medyssey Co., Ltd.
- Model
- ICVR55150
- Device description
- MIS CCM Alloy Straight Variable Rod, Ø5.5mm X 150mm
- Published
- 2017-05-09
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08809547361276 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08809547361276 | 08809547361276 | 8809547361276 |
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. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 688211503
- 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 |
|---|---|---|---|---|
| 08800311596863 | NA | PNPS-003 | 2026-03-12 | |
| 08800311596696 | NA | NNSS-002 | 2026-03-09 | |
| 08800311596665 | NA | NXVC-002 | 2026-02-19 | |
| 08800311596474 | Medyssey Poseidon OCT Spinal Fixation System | R35055 | 2026-01-30 | |
| 08800311596481 | Medyssey Poseidon OCT Spinal Fixation System | R35065 | 2026-01-30 | |
| 08800311596498 | Medyssey Poseidon OCT Spinal Fixation System | R35075 | 2026-01-30 | |
| 08800311596504 | Medyssey Poseidon OCT Spinal Fixation System | R35085 | 2026-01-30 | |
| 08800311596511 | Medyssey Poseidon OCT Spinal Fixation System | R35095 | 2026-01-30 | |
| 08800311596528 | Medyssey Poseidon OCT Spinal Fixation System | R35105 | 2026-01-30 | |
| 08800311596535 | Medyssey Poseidon OCT Spinal Fixation System | R35115 | 2026-01-30 | |
| 08800311596542 | Medyssey Poseidon OCT Spinal Fixation System | R35125 | 2026-01-30 | |
| 08800311596559 | Medyssey Poseidon OCT Spinal Fixation System | R35135 | 2026-01-30 | |
| 08800311596566 | Medyssey Poseidon OCT Spinal Fixation System | R35145 | 2026-01-30 | |
| 08800311596573 | Medyssey Poseidon OCT Spinal Fixation System | R35155 | 2026-01-30 | |
| 08800311596580 | Medyssey Poseidon OCT Spinal Fixation System | R35165 | 2026-01-31 | |
| 08800311596597 | Medyssey Poseidon OCT Spinal Fixation System | R35175 | 2026-01-30 | |
| 08800311596603 | Medyssey Poseidon OCT Spinal Fixation System | R35185 | 2026-01-30 | |
| 08800311596610 | Medyssey Poseidon OCT Spinal Fixation System | R35195 | 2026-01-30 | |
| 08800311595132 | NA | SPNDB-200 | 2026-01-27 | |
| 08800311595149 | NA | SPNDB-250 | 2026-01-27 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00840185382566 | 4CIS WILL PEDICLE SCREW SYSTEM | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED | NKB | 2026-05-25 |
| 00840185382573 | 4CIS WILL PEDICLE SCREW SYSTEM | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED | NKB | 2026-05-25 |
| 00840185382580 | 4CIS WILL PEDICLE SCREW SYSTEM | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED | NKB | 2026-05-25 |
| 00840185382597 | 4CIS WILL PEDICLE SCREW SYSTEM | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED | NKB | 2026-05-25 |
| 07290014381254 | ProMIS™ Fixation System | PREMIA SPINE LTD | NKB | 2026-05-25 |
| 07290014381261 | ProMIS™ Fixation System | PREMIA SPINE LTD | NKB | 2026-05-25 |
| 07290115935615 | Counter Torque ST | PREMIA SPINE LTD | NKB | 2026-05-25 |
| 06941312465757 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465764 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465771 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465788 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465795 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465801 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465818 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465825 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465832 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465849 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465856 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465887 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465894 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465900 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465559 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465566 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465573 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465580 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465597 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465603 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465610 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465627 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465634 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |