ATLANTIS ESSENTIALS™ Anterior Cervical Plate Syste
GUDID 20643169587315
SCREW G73733042013 4.0X13 SLF-TAP FIX 2P
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, sterile| Primary Device ID | 20643169587315 |
| NIH Device Record Key | 57392780-9ddd-4582-9d81-af0fce400d5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATLANTIS ESSENTIALS™ Anterior Cervical Plate Syste |
| Version Model Number | G73733042013 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 2 |
| 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 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 13 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169587311 [Unit of Use] |
| GS1 | 20643169587315 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152623
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-01-15 |
On-Brand Devices [ATLANTIS ESSENTIALS™ Anterior Cervical Plate Syste]
| 20643169587919 | SCREW G73733032015 4.0X15 SLF-DRL FIX 2P |
| 20643169587902 | SCREW G73733032014 4.0X14 SLF-DRL FIX 2P |
| 20643169587896 | SCREW G73733032013 4.0X13 SLF-DRL FIX 2P |
| 20643169587872 | SCREW G73733032011 4.0X11 SLF-DRL FIX 2P |
| 20643169587339 | SCREW G73733042015 4.0X15 SLF-TAP FIX 2P |
| 20643169587315 | SCREW G73733042013 4.0X13 SLF-TAP FIX 2P |
| 20643169587292 | SCREW G73733042011 4.0X11 SLF-TAP FIX 2P |
| 20643169575961 | SCREW G73733132019 4.0X19 SLF-DRL VAR 2P |
| 20643169575923 | SCREW PK2 G73733132015 4.0X15 SLF-DR VAR |
| 20643169575909 | SCREW PK2 G73733132013 4.0X13 SLF-DR VAR |
| 20643169575886 | SCREW PK2 G73733132011 4.0X11 SLF-DR VAR |
| 20643169575343 | SCREW PK2 G73733142015 4.0X15 SLF-TP VAR |
| 20643169575329 | SCREW PK2 G73733142013 4.0X13 SLF-TP VAR |
| 20643169575305 | SCREW PK2 G73733142011 4.0X11 SLF-TP VAR |
Trademark Results [ATLANTIS ESSENTIALS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ATLANTIS ESSENTIALS 86702189 5023923 Live/Registered |
Warsaw Orthopedic, Inc. 2015-07-23 |
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