ATLANTIS ® Anterior Cervical Plate System
GUDID 00613994466334
SCREW X1107033 4.25 X 13 SD VAS
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00613994466334 |
| NIH Device Record Key | a98de391-ad7e-47d9-ab3c-1d4da79ead0d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATLANTIS ® Anterior Cervical Plate System |
| Version Model Number | X1107033 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| 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 |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 4.25 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.25 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994466334 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063100
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
Moist Heat or Steam Sterilization
[00613994466334]
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 | 2015-09-02 |
On-Brand Devices [ATLANTIS ® Anterior Cervical Plate System]
| 00613994466358 | SCREW X1107035 4.25 X 15 SD VAS |
| 00613994466341 | SCREW X1107034 4.25 X 14 SD VAS |
| 00613994466334 | SCREW X1107033 4.25 X 13 SD VAS |
| 00613994466327 | SCREW X1107032 4.25 X 12 SD VAS |
| 00613994383822 | PLATE X0607174 ATL - 30MM - 1 LEV |
| 00613994383808 | PLATE X0607176 ATL - 35MM - 1 LEV |
| 00613994383785 | PLATE X0607178 ATL - 40MM - 1 LEV |
| 00613994383747 | PLATE X0607182 ATL - 87.5MM - 4 LEV |
| 00613994383730 | PLATE X0607183 ATL - 90MM - 4 LEV |
| 00613994383723 | PLATE X0607184 ATL - 92.5MM - 4 LEV |
| 00613994383716 | PLATE X0607185 ATL - 95MM - 4 LEV |
| 00673978010687 | CASE 176-510 ATLANTIS UPPER INS TRAY |
| 00673978010670 | CASE 176-509 ATLANTIS PLATE TRAY LID |
| 00673978010601 | CASE 176-502 ATLANTIS CASE LID |
Trademark Results [ATLANTIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ATLANTIS 98395224 not registered Live/Pending |
ABELARES GROUP, LLC 2024-02-07 |
 ATLANTIS 98395221 not registered Live/Pending |
ABELARES GROUP, LLC 2024-02-07 |
 ATLANTIS 97800362 not registered Live/Pending |
Fowler, Timothy L. 2023-02-17 |
 ATLANTIS 97681351 not registered Live/Pending |
BrainMaster Technologies, Inc. 2022-11-17 |
 ATLANTIS 97636579 not registered Live/Pending |
Wenzhou Xiduoli Sanitary Ware Co., Ltd. 2022-10-18 |
 ATLANTIS 97502702 not registered Live/Pending |
Kerzner International Resorts, Inc. 2022-07-14 |
 ATLANTIS 97459185 not registered Live/Pending |
Atlantis Memorials B.V. 2022-06-15 |
 ATLANTIS 90864327 not registered Live/Pending |
Kerzner International Resorts, Inc. 2021-08-04 |
 ATLANTIS 90494735 not registered Live/Pending |
E V International ltd 2021-01-28 |
 ATLANTIS 90232602 not registered Live/Pending |
CENTRE DE CONDITIONNEMENT PHYSIQUE ATLANTIS INC. 2020-10-02 |
 ATLANTIS 90040152 not registered Live/Pending |
MS Directional, LLC 2020-07-07 |
 ATLANTIS 88570065 not registered Live/Pending |
Vintae Luxury Wine Specialists, S.L.U. 2019-08-07 |
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