Axis Plate
GUDID 00842078117903
Screw Washer
EXTREMITY MEDICAL, LLC
Orthopaedic bone washer, non-sterile| Primary Device ID | 00842078117903 |
| NIH Device Record Key | aaa3daf4-f9b3-4beb-8c93-1886444ee650 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Axis Plate |
| Version Model Number | 148-35451 |
| Company DUNS | 832720358 |
| Company Name | EXTREMITY MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842078117903 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192592
FDA Product Code
| HTN | Washer, Bolt Nut |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
[00842078117903]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-04 |
| Device Publish Date | 2020-10-27 |
On-Brand Devices [Axis Plate]
| 00842078119815 | Locking Screw - 4.5 mm x 60 |
| 00842078119808 | Locking Screw - 4.5 mm x 55 |
| 00842078119792 | Locking Screw - 4.5 mm x 50 |
| 00842078119785 | Locking Screw - 4.5 mm x 45 |
| 00842078119778 | Locking Screw - 4.5 mm x 40 |
| 00842078119761 | Locking Screw - 4.5 mm x 35 |
| 00842078119754 | Non-Locking Screw - 4.5 mm x 60 |
| 00842078119747 | Non-Locking Screw - 4.5 mm x 55 |
| 00842078119730 | Non-Locking Screw - 4.5 mm x 50 |
| 00842078119723 | Non-Locking Screw - 4.5 mm x 45 |
| 00842078119716 | Non-Locking Screw - 4.5 mm x 40 |
| 00842078119709 | Non-Locking Screw - 4.5 mm x 35 |
| 00842078119693 | Non-Locking Screw - 4.5 mm x 14 |
| 00842078119686 | Non-Locking Screw - 4.5 mm x 12 |
| 00842078119679 | Locking Screw - 3.5 mm x 60 |
| 00842078119662 | Locking Screw - 3.5 mm x 55 |
| 00842078119655 | Locking Screw - 3.5 mm x 50 |
| 00842078119648 | Locking Screw - 3.5 mm x 45 |
| 00842078119631 | Locking Screw - 3.5 mm x 40 |
| 00842078119624 | Locking Screw - 3.5 mm x 35 |
| 00842078119617 | Locking Screw - 3.5 mm x 14 |
| 00842078119600 | Locking Screw - 3.5 mm x 12 |
| 00842078119594 | Non-Locking Screw - 3.5 mm x 60 |
| 00842078119587 | Non-Locking Screw - 3.5 mm x 55 |
| 00842078119570 | Non-Locking Screw - 3.5 mm x 50 |
| 00842078119563 | Non-Locking Screw - 3.5 mm x 45 |
| 00842078119556 | Non-Locking Screw - 3.5 mm x 40 |
| 00842078119549 | Non-Locking Screw - 3.5 mm x 35 |
| 00842078119532 | Non-Locking Screw - 3.5 mm x 14 |
| 00842078119525 | Non-Locking Screw - 3.5 mm x 12 |
| 00842078119280 | Plantar PlateDistal Medical Column, Right |
| 00842078119273 | Plantar Plate -Distal Medical Column , Left |
| 00842078119266 | Plantar Plate, Medium, Right |
| 00842078119259 | Plantar Plate, Medium, Left |
| 00842078119242 | Plantar Plate, Short, Right |
| 00842078119235 | Plantar Plate, Short, Left |
| 00842078119129 | Locking Screw - 4.5 mm x 14 |
| 00842078118504 | Locking Screw - 4.5 mm x 12 |
| 00842078118450 | Utility Plate (9 Hole) |
| 00842078118375 | Plantar Plate, Long, Right |
| 00842078118368 | Plantar Plate, Long, Left |
| 00842078117903 | Screw Washer |
| 00842078117859 | Locking Screw - 4.5 mm x 30 |
| 00842078117842 | Locking Screw - 4.5 mm x 28 |
| 00842078117835 | Locking Screw - 4.5 mm x 26 |
| 00842078117828 | Locking Screw - 4.5 mm x 24 |
| 00842078117811 | Locking Screw - 4.5 mm x 22 |
| 00842078117804 | Locking Screw - 4.5 mm x 20 |
| 00842078117798 | Locking Screw - 4.5 mm x 18 |
| 00842078117781 | Locking Screw - 4.5 mm x 16 |
Trademark Results [Axis Plate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AXIS PLATE 86325592 4653000 Live/Registered |
Spohn Global Enterprises LLC 2014-07-01 |
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