ICON
GUDID 18257200052790
8.5mm x 80mm Mono Axial Screw
ORTHOFIX INC.
Bone-screw internal spinal fixation system| Primary Device ID | 18257200052790 |
| NIH Device Record Key | 47d06215-0ceb-4da5-b305-de9f36b0be8a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ICON |
| Version Model Number | 54-4880 |
| 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 | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 80 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200052790 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111448
FDA Product Code
| NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
Moist Heat or Steam Sterilization
[18257200052790]
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 [ICON]
| 18257200065431 | Reduction Screw Body with Extended Tab |
| 18257200065417 | Multi-axial Reduction Body |
| 18257200052837 | 14mm Offset Body Assembly |
| 18257200052820 | 11mm Offset Body Assembly |
| 18257200052813 | 8mm Offset Body Assembly |
| 18257200052806 | Multi Axial Body |
| 18257200052790 | 8.5mm x 80mm Mono Axial Screw |
| 18257200052783 | 8.5mm x 75mm Mono Axial Screw |
| 18257200052776 | 8.5mm x 70mm Mono Axial Screw |
| 18257200052769 | 8.5mm x 65mm Mono Axial Screw |
| 18257200052752 | 8.5mm x 60mm Mono Axial Screw |
| 18257200052745 | 8.5mm x 55mm Mono Axial Screw |
| 18257200052738 | 8.5mm x 50mm Mono Axial Screw |
| 18257200052721 | 8.5mm x 45mm Mono Axial Screw |
| 18257200052714 | 8.5mm x 40mm Mono Axial Screw |
| 18257200052707 | 8.5mm x 35mm Mono Axial Screw |
| 18257200052691 | 8.5mm x 30mm Mono Axial Screw |
| 18257200052684 | 8.5mm x 25mm Mono Axial Screw |
| 18257200052677 | 7.5mm x 80mm Mono Axial Screw |
| 18257200052660 | 7.5mm x 75mm Mono Axial Screw |
| 18257200052653 | 7.5mm x 70mm Mono Axial Screw |
| 18257200052646 | 7.5mm x 65mm Mono Axial Screw |
| 18257200052639 | 7.5mm x 60mm Mono Axial Screw |
| 18257200052622 | 7.5mm x 55mm Mono Axial Screw |
| 18257200052615 | 7.5mm x 50mm Mono Axial Screw |
| 18257200052608 | 7.5mm x 45mm Mono Axial Screw |
| 18257200052592 | 7.5mm x 40mm Mono Axial Screw |
| 18257200052585 | 7.5mm x 35mm Mono Axial Screw |
| 18257200052578 | 7.5mm x 30mm Mono Axial Screw |
| 18257200052561 | 7.5mm x 25mm Mono Axial Screw |
| 18257200052554 | 6.5mm x 80mm Mono Axial Screw |
| 18257200052547 | 6.5mm x 75mm Mono Axial Screw |
| 18257200052530 | 6.5mm x 70mm Mono Axial Screw |
| 18257200052523 | 6.5mm x 65mm Mono Axial Screw |
| 18257200052516 | 6.5mm x 60mm Mono Axial Screw |
| 18257200052509 | 6.5mm x 55mm Mono Axial Screw |
| 18257200052493 | 6.5mm x 50mm Mono Axial Screw |
| 18257200052486 | 6.5mm x 45mm Mono Axial Screw |
| 18257200052479 | 6.5mm x 40mm Mono Axial Screw |
| 18257200052462 | 6.5mm x 35mm Mono Axial Screw |
| 18257200052455 | 6.5mm x 30mm Mono Axial Screw |
| 18257200052448 | 6.5mm x 25mm Mono Axial Screw |
| 18257200052431 | 5.5mm x 75mm Mono Axial Screw |
| 18257200052424 | 5.5mm x 70mm Mono Axial Screw |
| 18257200052417 | 5.5mm x 65mm Mono Axial Screw |
| 18257200052400 | 5.5mm x 60mm Mono Axial Screw |
| 18257200052394 | 5.5mm x 55mm Mono Axial Screw |
| 18257200052387 | 5.5mm x 50mm Mono Axial Screw |
| 18257200052370 | 5.5mm x 45mm Mono Axial Screw |
| 18257200052363 | 5.5mm x 40mm Mono Axial Screw |
Trademark Results [ICON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ICON 98708053 not registered Live/Pending |
Vandor Corporation 2024-08-20 |
 ICON 98593063 not registered Live/Pending |
SARL XPLORER 2024-06-10 |
 ICON 98578673 not registered Live/Pending |
Tyler Candle Company, L.L.C. 2024-05-31 |
 ICON 98548381 not registered Live/Pending |
Green, Jermon D 2024-05-13 |
 ICON 98508431 not registered Live/Pending |
UFP Industries, Inc. 2024-04-18 |
 ICON 98482609 not registered Live/Pending |
Icon Scientific Limited 2024-04-03 |
 ICON 98482528 not registered Live/Pending |
Icon Scientific Limited 2024-04-03 |
 ICON 98453341 not registered Live/Pending |
M.P.T. Racing Inc 2024-03-17 |
 ICON 98422018 not registered Live/Pending |
E. & J. GALLO WINERY 2024-02-26 |
 ICON 98311970 not registered Live/Pending |
True Temper Sports, Inc. 2023-12-13 |
 ICON 98275939 not registered Live/Pending |
Capital One Financial Corporation 2023-11-17 |
 ICON 98167084 not registered Live/Pending |
Bushnell Inc. 2023-09-06 |
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