PHOENIX
GUDID 18257200116041
Pre-Lordosed Rod with Hex and Taper anodized, 150mm
ORTHOFIX INC.
Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 18257200116041 |
| NIH Device Record Key | b2c05874-51df-4199-a35b-58309cb661eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PHOENIX |
| Version Model Number | 20-4150 |
| 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
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
| Length | 150 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200116041 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K122901
FDA Product Code
| NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
Moist Heat or Steam Sterilization
[18257200116041]
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 | 2016-03-14 |
On-Brand Devices [PHOENIX]
| 18257200116218 | Straight Rod w/Hex anodized, 800mm |
| 18257200116201 | Straight Rod with Hex anodized, 600mm |
| 18257200116195 | Straight Rod with Hex anodized, 450mm |
| 18257200116188 | Straight Rod with Hex and Taper anodized, 200mm |
| 18257200116171 | Straight Rod with Hex and Taper anodized, 180mm |
| 18257200116164 | Straight Rod with Hex and Taper anodized, 160mm |
| 18257200116157 | Straight Rod with Hex and Taper anodized, 140mm |
| 18257200116140 | Straight Rod with Hex and Taper anodized, 120mm |
| 18257200116133 | Straight Rod with Hex and Taper anodized, 110mm |
| 18257200116126 | Straight Rod with Hex and Taper anodized, 100mm |
| 18257200116119 | Straight Rod with Hex and Taper anodized, 90mm |
| 18257200116102 | Straight Rod with Hex and Taper anodized, 80mm |
| 18257200116096 | Straight Rod with Hex and Taper anodized, 70mm |
| 18257200116089 | Straight Rod with Hex and Taper anodized, 60mm |
| 18257200116072 | Straight Rod with Hex and Taper anodized, 50mm |
| 18257200116065 | Straight Rod with Hex and Taper anodized, 40mm |
| 18257200116058 | Pre-Lordosed Rod with Hex and Taper, 200mm |
| 18257200116041 | Pre-Lordosed Rod with Hex and Taper anodized, 150mm |
| 18257200116034 | Pre-Lordosed Rod with Hex and Taper anodized, 140mm |
| 18257200116027 | Pre-Lordosed Rod with Hex and Taper anodized, 130mm |
| 18257200116010 | Pre-Lordosed Rod with Hex and Taper anodized, 120mm |
| 18257200116003 | Pre-Lordosed Rod with Hex and Taper anodized, 110mm |
| 18257200115990 | Pre-Lordosed Rod with Hex and Taper anodized, 100mm |
| 18257200115983 | Pre-Lordosed Rod with Hex and Taper anodized, 90mm |
| 18257200115976 | Pre-Lordosed Rod with Hex and Taper anodized, 80mm |
| 18257200115969 | Pre-Lordosed Rod with Hex and Taper anodized, 75mm |
| 18257200115952 | Pre-Lordosed Rod with Hex and Taper anodized, 70mm |
| 18257200115945 | Pre-Lordosed Rod with Hex and Taper anodized, 65mm |
| 18257200115938 | Pre-Lordosed Rod with Hex and Taper anodized, 60mm |
| 18257200115921 | Pre-Lordosed Rod with Hex and Taper anodized, 55mm |
| 18257200115914 | Pre-Lordosed Rod with Hex and Taper anodized, 50mm |
| 18257200115907 | Pre-Lordosed Rod with Hex and Taper anodized, 45mm |
| 18257200115891 | Pre-Lordosed Rod with Hex and Taper anodized, 40mm |
| 18257200115884 | Pre-Lordosed Rod with Hex and Taper anodized, 35mm |
| 18257200080229 | Pre-Lordosed Rod with Hex and Taper, 200mm |
| 18257200029808 | CoCr Straight Rod w/Hex, 800mm |
| 18257200029792 | CoCr Straight Rod w/Hex, 600mm |
| 18257200029785 | CoCr Straight Rod w/Hex, 450mm |
| 18257200029778 | CoCr Straight Rod w/Hex and Taper, 200mm |
| 18257200029761 | CoCr Straight Rod w/Hex and Taper, 180mm |
| 18257200029754 | CoCr Straight Rod w/Hex and Taper, 160mm |
| 18257200029747 | CoCr Straight Rod w/Hex and Taper, 140mm |
| 18257200029730 | CoCr Straight Rod w/Hex and Taper, 120mm |
| 18257200029723 | CoCr Straight Rod w/Hex and Taper, 110mm |
| 18257200029716 | CoCr Straight Rod w/Hex and Taper, 100mm |
| 18257200029709 | CoCr Straight Rod w/Hex and Taper, 90mm |
| 18257200029693 | CoCr Straight Rod w/Hex and Taper, 80mm |
| 18257200029686 | CoCr Straight Rod w/Hex and Taper, 70mm |
| 18257200029679 | CoCr Straight Rod w/Hex and Taper, 60mm |
| 18257200029662 | CoCr Straight Rod w/Hex and Taper, 50mm |
Trademark Results [PHOENIX]
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