Nex-D2
- Primary DI
- 00840314114570
- Brand
- Nex-D2
- Company
- NEXT ORTHOSURGICAL, INC.
- Model
- CBAEJ-50025
- Published
- 2024-08-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- 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 |
|---|---|---|---|---|
| 00840314114570 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00840314114570 | 00840314114570 | 840314114570 | 0840314114570 |
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
- 046767258
- 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
- false
- 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 |
|---|---|---|---|---|
| 00840314165923 | Nex-D2 | CBFBJ-70140 | CBFBJ-70140 | 2024-09-05 |
| 00840314165930 | Nex-D2 | CBFBJ-70145 | CBFBJ-70145 | 2024-09-05 |
| 00840314165947 | Nex-D2 | CBFBJ-70150 | CBFBJ-70150 | 2024-09-05 |
| 00840314165954 | Nex-D2 | CBFBJ-78020 | CBFBJ-78020 | 2024-09-05 |
| 00840314165961 | Nex-D2 | CBFBJ-78025 | CBFBJ-78025 | 2024-09-05 |
| 00840314165978 | Nex-D2 | CBFBJ-78030 | CBFBJ-78030 | 2024-09-05 |
| 00840314165985 | Nex-D2 | CBFBJ-78035 | CBFBJ-78035 | 2024-09-05 |
| 00840314165992 | Nex-D2 | CBFBJ-78040 | CBFBJ-78040 | 2024-09-05 |
| 00840314166005 | Nex-D2 | CBFBJ-78045 | CBFBJ-78045 | 2024-09-05 |
| 00840314166012 | Nex-D2 | CBFBJ-78050 | CBFBJ-78050 | 2024-09-05 |
| 00840314166029 | Nex-D2 | CBFBJ-78055 | CBFBJ-78055 | 2024-09-05 |
| 00840314166036 | Nex-D2 | CBFBJ-78060 | CBFBJ-78060 | 2024-09-05 |
| 00840314166043 | Nex-D2 | CBFBJ-78065 | CBFBJ-78065 | 2024-09-05 |
| 00840314166050 | Nex-D2 | CBFBJ-78070 | CBFBJ-78070 | 2024-09-05 |
| 00840314166067 | Nex-D2 | CBFBJ-78075 | CBFBJ-78075 | 2024-09-05 |
| 00840314166074 | Nex-D2 | CBFBJ-78080 | CBFBJ-78080 | 2024-09-05 |
| 00840314166081 | Nex-D2 | CBFBJ-78085 | CBFBJ-78085 | 2024-09-05 |
| 00840314166098 | Nex-D2 | CBFBJ-78090 | CBFBJ-78090 | 2024-09-05 |
| 00840314166104 | Nex-D2 | CBFBJ-78095 | CBFBJ-78095 | 2024-09-05 |
| 00840314166111 | Nex-D2 | CBFBJ-78100 | CBFBJ-78100 | 2024-09-05 |
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 |