EUROPA™ Pedicle Screw
GUDID 00811638031133
Ø7.5 X 40mm EUROPA™ Pedicle Screw
MIRUS LLC
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 | 00811638031133 |
| NIH Device Record Key | e4afe92c-1a8f-441c-a647-3637181b7329 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EUROPA™ Pedicle Screw |
| Version Model Number | 1-2-7540 |
| Company DUNS | 080311078 |
| Company Name | MIRUS 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 | 00811638031133 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180337
FDA Product Code
| NKB | Thoracolumbosacral Pedicle Screw System |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
[00811638031133]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-01 |
| Device Publish Date | 2023-02-21 |
On-Brand Devices [EUROPA™ Pedicle Screw ]
| 00811638030426 | Ø8.5 X 55mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030419 | Ø8.5 X 50mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030402 | Ø8.5 X 45mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030396 | Ø8.5 X 40mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030389 | Ø8.5 X 35mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030372 | Ø8.5 X 30mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030365 | Ø7.5 X 80mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030358 | Ø7.5 X 75mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030341 | Ø7.5 X 70mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030334 | Ø7.5 X 65mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030327 | Ø7.5 X 60mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030310 | Ø7.5 X 55mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030303 | Ø7.5 X 50mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030280 | Ø7.5 X 40mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030273 | Ø7.5 X 35mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030266 | Ø7.5 X 30mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030259 | Ø6.5 X 80mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030242 | Ø6.5 X 75mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030235 | Ø6.5 X 70mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030228 | Ø6.5 X 65mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030211 | Ø6.5 X 60mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030204 | Ø6.5 X 55mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030198 | Ø6.5 X 50mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030174 | Ø6.5 X 40mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030167 | Ø6.5 X 35mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030150 | Ø6.5 X 30mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030143 | Ø6.5 X 25mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030136 | Ø5.5 X 60mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030129 | Ø5.5 X 55mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030112 | Ø5.5 X 50mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030105 | Ø5.5 X 45mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030099 | Ø5.5 X 40mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030082 | Ø5.5 X 35mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030075 | Ø5.5 X 30mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030068 | Ø5.5 X 25mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030051 | Ø4.5 X 50mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030044 | Ø4.5 X 45mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030037 | Ø4.5 X 40mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030020 | Ø4.5 X 35mm EUROPA™ MIS Pedicle Screw, Cannulated |
| 00811638030938 | Ø6.5 X 50mm EUROPA™ Pedicle Screw |
| 00811638030921 | Ø6.5 X 45mm EUROPA™ Pedicle Screw |
| 00811638030914 | Ø6.5 X 40mm EUROPA™ Pedicle Screw |
| 00811638030907 | Ø6.5 X 35mm EUROPA™ Pedicle Screw |
| 00811638030891 | Ø6.5 X 30mm EUROPA™ Pedicle Screw |
| 00811638030884 | Ø6.5 X 25mm EUROPA™ Pedicle Screw |
| 00811638030877 | Ø6.5 X 80mm EUROPA™ Pedicle Screw, Cannulated |
| 00811638030860 | Ø6.5 X 75mm EUROPA™ Pedicle Screw, Cannulated |
| 00811638030853 | Ø6.5 X 70mm EUROPA™ Pedicle Screw, Cannulated |
| 00811638030846 | Ø6.5 X 65mm EUROPA™ Pedicle Screw, Cannulated |
| 00811638030839 | Ø6.5 X 60mm EUROPA™ Pedicle Screw, Cannulated |
Trademark Results [EUROPA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EUROPA 98460755 not registered Live/Pending |
The Cadmus Group, LLC 2024-03-21 |
 EUROPA 98403400 not registered Live/Pending |
MiRus LLC 2024-02-13 |
 EUROPA 97933103 not registered Live/Pending |
AXELERA AI B.V. 2023-05-12 |
 EUROPA 97250998 not registered Live/Pending |
Budd, Marc L 2022-02-02 |
 EUROPA 97016498 not registered Live/Pending |
MiRus, LLC 2021-09-08 |
 EUROPA 90770807 not registered Live/Pending |
Gentenaar, Henry 2021-06-12 |
 EUROPA 90296938 not registered Live/Pending |
Livermoretech Inc. 2020-11-03 |
 EUROPA 88830029 not registered Live/Pending |
Forest River, Inc. 2020-03-11 |
 EUROPA 88621359 not registered Live/Pending |
MiRus, LLC 2019-09-18 |
 EUROPA 88024316 not registered Dead/Abandoned |
MiRus, LLC 2018-07-03 |
 EUROPA 87593359 not registered Dead/Abandoned |
MiRus, LLC 2017-09-01 |
 EUROPA 87342562 5285462 Live/Registered |
Distelli, Inc. 2017-02-20 |
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