Clydesdale™ Spinal System
GUDID 00613994248435
CASE 2940102 4 INS TRAYS 1 AND 2
MEDTRONIC SOFAMOR DANEK, INC.
Instrument tray| Primary Device ID | 00613994248435 |
| NIH Device Record Key | ae8f3650-6cca-40dc-a13d-e024f278c3a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clydesdale™ Spinal System |
| Version Model Number | 2940102 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994248435 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190840
FDA Product Code
| FSM | TRAY, SURGICAL, INSTRUMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
[00613994248435]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2017-10-30 |
On-Brand Devices [Clydesdale™ Spinal System]
| 00613994866523 | INSERTER 2942001 DL INSERTER |
| 00613994725653 | TRIAL X1209240 8X40 0 DEG LORDOSIS MOD |
| 00613994725646 | TRIAL X1209245 8X45 0 DEG LORDOSIS MOD |
| 00613994725639 | TRIAL X1209250 8X50 0 DEG LORDOSIS MOD |
| 00613994725622 | TRIAL X1209255 8X55 0 DEG LORDOSIS MOD |
| 00613994725615 | TRIAL X1209340 10X40 0 DEG LORDOSIS MOD |
| 00613994725608 | TRIAL X1209345 10X45 0 DEG LORDOSIS MOD |
| 00613994725592 | TRIAL X1209350 10X50 0 DEG LORDOSIS MOD |
| 00613994725585 | TRIAL X1209355 10X55 0 DEG LORDOSIS MOD |
| 00613994725578 | TRIAL X1209440 12X40 0 DEG LORDOSIS MOD |
| 00613994725561 | TRIAL X1209445 12X45 0 DEG LORDOSIS MOD |
| 00613994725554 | TRIAL X1209450 12X50 0 DEG LORDOSIS MOD |
| 00613994725547 | TRIAL X1209455 12X55 0 DEG LORDOSIS MOD |
| 00613994725530 | TRIAL X1209540 14X40 0 DEG LORDOSIS MOD |
| 00613994725523 | TRIAL X1209545 14X45 0 DEG LORDOSIS MOD |
| 00613994725516 | TRIAL X1209550 14X50 0 DEG LORDOSIS MOD |
| 00613994725509 | TRIAL X1209555 14X55 0 DEG LORDOSIS MOD |
| 00613994725493 | TRIAL X1209640 16X40 0 DEG LORDOSIS MOD |
| 00613994725486 | TRIAL X1209645 16X45 0 DEG LORDOSIS MOD |
| 00613994725479 | TRIAL X1209650 16X50 0 DEG LORDOSIS MOD |
| 00613994725462 | TRIAL X1209655 16X55 0 DEG LORDOSIS MOD |
| 00613994724571 | HANDLE X1209145 TRIAL MODULAR |
| 00613994711427 | DISTRACTOR X1009437 CLYDES 12 DEG 8X45 |
| 00613994711410 | DISTRACTOR X1009438 CLYDES 12 DEG 8X50 |
| 00613994711403 | DISTRACTOR X1009439 CLYDES 12 DEG 8X55 |
| 00613994711397 | DISTRACTOR X1009440 CLYDES 12 DEG 10X45 |
| 00613994711380 | DISTRACTOR X1009441 CLYDES 12 DEG 10X50 |
| 00613994711373 | DISTRACTOR X1009442 CLYDES 12 DEG 10X55 |
| 00613994711366 | DISTRACTOR X1009443 CLYDES 12 DEG 12X45 |
| 00613994711359 | DISTRACTOR X1009444 CLYDES 12 DEG 12X50 |
| 00613994711342 | DISTRACTOR X1009445 CLYDES 12 DEG 12X55 |
| 00613994711335 | DISTRACTOR X1009446 CLYDES 12 DEG 14X45 |
| 00613994711328 | DISTRACTOR X1009447 CLYDES 12 DEG 14X50 |
| 00613994711311 | DISTRACTOR X1009448 CLYDES 12 DEG 14X55 |
| 00613994706119 | INSTRUMENT X0909751 CLYDE 22W 8X45 TRIAL |
| 00613994706102 | INSTRUMENT X0909752 CLYDE 22W 8X50 TRIAL |
| 00613994706096 | INSTRUMENT X0909753 CLYDE 22W 8X55 TRIAL |
| 00613994706089 | INSTRUMENT X0909754 CLYDE 22W 10X45 TRL |
| 00613994706072 | INSTRUMENT X0909755 CLYDE 22W 10X50 TRL |
| 00613994706065 | INSTRUMENT X0909756 CLYDE 22W 10X55 TRL |
| 00613994706058 | INSTRUMENT X0909757 CLYDE 22W 12X45 TRL |
| 00613994706041 | INSTRUMENT X0909758 CLYDE 22W 12X50 TRL |
| 00613994706034 | INSTRUMENT X0909759 CLYDE 22W 12X55 TRL |
| 00613994706027 | INSTRUMENT X0909760 CLYDE 22W 14X45 TRL |
| 00613994706010 | INSTRUMENT X0909761 CLYDE 22W 14X50 TRL |
| 00613994706003 | INSTRUMENT X0909762 CLYDE 22W 14X55 TRL |
| 00613994705006 | CAGE X0909600 CLYDESDALE PK IB 12 8X45 |
| 00613994704993 | CAGE X0909601 CLYDESDALE PK IB 12 10X45 |
| 00613994704986 | CAGE X0909602 CLYDESDALE PK IB 12 12X45 |
| 00613994704979 | CAGE X0909603 CLYDESDALE PK IB 12 14X45 |
Trademark Results [Clydesdale]
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