FIREBIRD
GUDID 18257200010790
10.5mm x 100mm Bone Screw, Self-Tapping
ORTHOFIX INC.
Bone-screw internal spinal fixation system| Primary Device ID | 18257200010790 |
| NIH Device Record Key | aa11c90b-b6ee-4c9d-82ff-80abcceb26f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FIREBIRD |
| Version Model Number | 44-5010 |
| Company DUNS | 927083808 |
| Company Name | ORTHOFIX INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 10.5 Millimeter |
| Length | 100 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200010790 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K081684
FDA Product Code
| NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
[18257200010790]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-24 |
On-Brand Devices [FIREBIRD]
| 18257200116515 | 120mm Rod, Pre-Lordosed, anodized |
| 18257200116508 | 110mm Rod Pre-Lordosed, anodized |
| 18257200116492 | 100mm Rod, Pre-Lordosed, anodized |
| 18257200116485 | 90mm Rod, Pre-Lordosed, anodized |
| 18257200116478 | 80mm Rod, Pre-Lordosed, anodized |
| 18257200116461 | 75mm Rod, Pre-Lordosed, anodized |
| 18257200116454 | 70mm Rod, Pre-Lordosed, anodized |
| 18257200116447 | 65mm Rod, Pre-Lordosed, anodized |
| 18257200116430 | 60mm Rod, Pre-Lordosed, anodized |
| 18257200116423 | 55mm Rod, Pre-Lordosed, anodized |
| 18257200116416 | 50mm Rod, Pre-Lordosed, anodized |
| 18257200116393 | 40mm Rod, Pre-Lordosed, anodized |
| 18257200116386 | 35mm Rod, Pre-Lordosed, anodized |
| 18257200116379 | 800mm Rod, diameter 5.5mm, titanium, anodized |
| 18257200116362 | 600mm Rod, diameter 5.5mm, titanium, anodized |
| 18257200116355 | 450mm Rod, diameter 5.5 mm, titanium, anodized |
| 18257200116348 | 200mm Rod, diameter 5.5mm, titanium, anodized |
| 18257200116331 | 180mm Rod, diameter 5.5mm, titanium, anodized |
| 18257200116324 | 160mm Rod, diameter 5.5mm, titanium, anodized |
| 18257200116317 | 140mm Rod, diameter 5.5mm, titanium, anodized |
| 18257200116300 | 120mm Rod, diameter 5.5mm, titanium, anodized |
| 18257200116294 | 110mm Rod, diameter 5.5mm, titanium, anodized |
| 18257200116287 | 100mm Rod, diameter 5.5mm, titanium, anodized |
| 18257200116270 | 90mm Rod, diameter 5.5mm, titanium, anodized |
| 18257200116263 | 80mm Rod, diameter 5.5mm, titanium, anodized |
| 18257200116256 | 70mm Rod, diameter 5.5 mm, titanium, anodized |
| 18257200116249 | 60mm Rod, diameter 5.5 millimeter titanium anodized |
| 18257200116232 | 50mm Rod diameter 5.5mm titanium anodized |
| 18257200116225 | 40mm Rod, diameter 5.5mm titanium anodized |
| 18257200114832 | 7.5MMX95MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114825 | 7.5MMX90MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114818 | 7.5MMX85MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114801 | 7.5MMX80MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114795 | 7.5MMX75MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114788 | 7.5MMX70MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114771 | 7.5MMX65MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114764 | 7.5MMX60MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114757 | 7.5MMX55MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114740 | 7.5MMX50MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114733 | 7.5MMX45MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114726 | 7.5MMX40MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114719 | 7.5MMX35MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114702 | 7.5MMX30MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114696 | 7.5MMX25MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114689 | 7.5MM X 110MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114672 | 7.5MM X 100MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114665 | 6.5MMX95MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114658 | 6.5MMX90MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114641 | 6.5MMX85MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
| 18257200114634 | 6.5MMX80MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED |
Trademark Results [FIREBIRD]
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