Firebird
- Primary DI
- 18257200113149
- Brand
- Firebird
- Company
- ORTHOFIX INC.
- Model
- 44-5010 AF
- Device description
- 10.5MM X 100MM MODULAR BONE SCREW SELF-TAPPING
- Published
- 2018-05-18
- 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 |
|---|---|---|---|---|
| 18257200113149 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 18257200113149 | 18257200113149 |
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
- 927083808
- Device count
- 1
- DM exempt
- true
- 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
- true
- 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 |
|---|---|---|---|---|
| 18257200068166 | PILLAR XL | 72-1909 | 2019-03-19 | |
| 18257200081387 | CONSTRUX - PEEK VBR | 450217-0001 | 48-0010 | 2020-02-03 |
| 18257200131969 | PEMF - PHYSIO-STIM | 655302-0001 | 5302 | 2020-01-16 |
| 18257200131976 | PEMF - PHYSIO-STIM | 655303-0001 | 5303 | 2020-01-16 |
| 18257200131983 | PEMF - PHYSIO-STIM | 655313-0001 | 5313 | 2020-01-16 |
| 18257200131990 | PEMF - PHYSIO-STIM | 655314-0001 | 5314L | 2020-01-16 |
| 18257200132003 | PEMF - PHYSIO-STIM | 655314-0101 | 5314R | 2020-01-16 |
| 18257200132010 | PEMF - PHYSIO-STIM | 655315-0001 | 5315 | 2020-01-16 |
| 18257200022151 | FORZA | 87-1209SP | 2019-09-24 | |
| 18257200022168 | FORZA | 87-1210SP | 2019-09-24 | |
| 18257200022175 | FORZA | 87-1211SP | 2019-09-24 | |
| 18257200022182 | FORZA | 87-1212SP | 2019-09-24 | |
| 18257200022199 | FORZA | 87-1213SP | 2019-09-24 | |
| 18257200022205 | FORZA | 87-1214SP | 2019-09-24 | |
| 18257200022212 | FORZA | 87-1215SP | 2019-09-24 | |
| 18257200022229 | FORZA | 87-1216SP | 2019-09-24 | |
| 18257200022236 | FORZA | 87-1308SP | 2019-09-24 | |
| 18257200022243 | FORZA | 87-1309SP | 2019-09-24 | |
| 18257200022250 | FORZA | 87-1310SP | 2019-09-24 | |
| 18257200022267 | FORZA | 87-1311SP | 2019-09-24 |
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 |