MySpine
GUDID 07630345752901
MySpine S2-SI right guide
Medacta International SA
Orthopaedic prosthesis implantation instrument, single-use| Primary Device ID | 07630345752901 |
| NIH Device Record Key | 00d2bb5c-6979-4868-b52f-0f38965a4e83 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MySpine |
| Version Model Number | 7.0732 |
| Company DUNS | 488227125 |
| Company Name | Medacta International SA |
| 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 | true |
| 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 | 07630345752901 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220888
FDA Product Code
| PQC | Pedicle Screw Placement Guide |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
[07630345752901]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-07 |
| Device Publish Date | 2022-05-30 |
On-Brand Devices [MySpine ]
| 07630040716888 | MySpine LP drill pilot guide L05 |
| 07630040716864 | MySpine LP drill pilot guide L04 |
| 07630040716840 | MySpine LP drill pilot guide L03 |
| 07630040716826 | MySpine LP drill pilot guide L02 |
| 07630040716802 | MySpine LP drill pilot guide L01 |
| 07630040716789 | MySpine LP drill pilot guide T12 |
| 07630040716765 | MySpine LP drill pilot guide T11 |
| 07630040716741 | MySpine LP drill pilot guide T10 |
| 07630040716727 | MySpine LP drill pilot guide T09 |
| 07630040716703 | MySpine LP drill pilot guide T08 |
| 07630040716680 | MySpine LP drill pilot guide T07 |
| 07630040716666 | MySpine LP drill pilot guide T06 |
| 07630040716642 | MySpine LP drill pilot guide T05 |
| 07630040716628 | MySpine LP drill pilot guide T04 |
| 07630040716604 | MySpine LP drill pilot guide T03 |
| 07630040716581 | MySpine LP drill pilot guide T02 |
| 07630040716567 | MySpine LP drill pilot guide T01 |
| 07630971257870 | MySpine-MC drill guide L06 |
| 07630971257832 | MySpine-MC vertebra L06 |
| 07630040717571 | MySpine-MC drill guide S01 |
| 07630040717557 | MySpine-MC drill guide L05 |
| 07630040717533 | MySpine-MC drill guide L04 |
| 07630040717519 | MySpine-MC drill guide L03 |
| 07630040717496 | MySpine-MC drill guide L02 |
| 07630040717472 | MySpine-MC drill guide L01 |
| 07630040717458 | MySpine-MC guide S01 |
| 07630040717434 | MySpine-MC guide L05 |
| 07630040717410 | MySpine-MC guide L04 |
| 07630040717397 | MySpine-MC guide L03 |
| 07630040717373 | MySpine-MC guide L02 |
| 07630040717359 | MySpine-MC guide L01 |
| 07630040717335 | MySpine-MC vertebra S01 |
| 07630040717311 | MySpine-MC vertebra L05 |
| 07630040717298 | MySpine-MC vertebra L04 |
| 07630040717274 | MySpine-MC vertebra L03 |
| 07630040717250 | MySpine-MCvertebra L02 |
| 07630040717236 | MySpine-MC vertebra L01 |
| 07630971262737 | MySpine LP drill pilot guide T13 STERILE |
| 07630971262720 | MySpine LP drill pilot guide T13 |
| 07630971257887 | MySpine MC drill guide L06 STERILE |
| 07630971257863 | MySpine MC guide L06 STERILE |
| 07630971257856 | MySpine MC guide L06 |
| 07630971257849 | MySpine MC vertebra L06 STERILE |
| 07630971257825 | MySpine LP drill pilot guide L06 STERILE |
| 07630971257818 | MySpine LP drill pilot guide L06 |
| 07630971257740 | Full Spine Model Short |
| 07630345752918 | MySpine S2-SI right guide STE |
| 07630345752901 | MySpine S2-SI right guide |
| 07630345752895 | MySpine S2-SI left guide STE |
| 07630345752888 | MySpine S2-SI left guide |
Trademark Results [MySpine]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MYSPINE 79072327 3828498 Live/Registered |
Medacta International SA 2009-07-13 |
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