PYRAMID® Anterior Plate Fixation System
GUDID 00721902337666
SCREW 8968645 XANTUS BONE FAS 6.5X45MM
MEDTRONIC SOFAMOR DANEK, INC.
Metallic spinal fusion cage, non-sterile| Primary Device ID | 00721902337666 |
| NIH Device Record Key | cce9a6b6-28b3-4de7-bce3-efc6089011d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PYRAMID® Anterior Plate Fixation System |
| Version Model Number | 8968645 |
| 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 | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 6.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00721902337666 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K013665
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
Moist Heat or Steam Sterilization
[00721902337666]
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 | 2015-07-30 |
On-Brand Devices [PYRAMID® Anterior Plate Fixation System]
| 00613994116819 | SCREW X1105414 BONE SCREW 6.5X50MM TI |
| 00613994116802 | SCREW X1105413 BONE SCREW 6.5X45MM TI |
| 00613994116796 | SCREW X1105412 BONE SCREW 6.5X40MM TI |
| 00613994116789 | SCREW X1105411 BONE SCREW 6.5X35MM TI |
| 00613994116772 | SCREW X1105410 BONE SCREW 6.5X30MM TI |
| 00613994116765 | SCREW X1105409 BONE SCREW 6.5X25MM TI |
| 00721902937057 | 6.5X55 TAPERED BONE SCREW |
| 00721902937040 | 6.5X50 TAPERED BONE SCREW |
| 00721902337666 | SCREW 8968645 XANTUS BONE FAS 6.5X45MM |
| 00721902337659 | SCREW 8968640 XANTUS BONE FAS 6.5X40MM |
| 00721902337635 | SCREW 8968635 PYRMD BONE FAS 6.5X35MM |
| 00721902337628 | SCREW 8968630 PYRMD BONE FAS 6.5X30MM |
| 00721902337611 | SCREW 8968625 PYRMD BONE FAS 6.5X25MM |
| 00721902214547 | PLATE 8969227 COVER PLATE 27MM |
| 00721902214523 | PLATE 8969225 COVER PLATE 25MM |
| 00721902214516 | PLATE 8969223 COVER PLATE 23MM |
| 00721902214493 | PLATE 8969221 COVER PLATE 21MM |
| 00721902214486 | PLATE 8969219 COVER PLATE 19MM |
| 00721902214479 | PLATE 8969217 COVER PLATE 17MM |
| 00721902214455 | PLATE 8969127 PLATE 27MM |
| 00721902214448 | PLATE 8969125 PLATE 25MM |
| 00721902214431 | PLATE 8969123 PLATE 23MM |
| 00721902214417 | PLATE 8969121 PLATE 21MM |
| 00721902214394 | PLATE 8969119 PLATE 19MM |
| 00721902214363 | PLATE 8969117 PLATE 17MM |
Trademark Results [PYRAMID]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PYRAMID 98779700 not registered Live/Pending |
Venturely Inc. 2024-10-01 |
 PYRAMID 98778014 not registered Live/Pending |
International E-Z Up, Inc. 2024-09-30 |
 PYRAMID 98611116 not registered Live/Pending |
PYRAMID Business Systems, Inc. 2024-06-20 |
 PYRAMID 98474181 not registered Live/Pending |
Pyramid LLC 2024-03-29 |
 PYRAMID 98067151 not registered Live/Pending |
Break Even Golf LLC 2023-06-30 |
 PYRAMID 97766475 not registered Live/Pending |
Pyramid Design & Manufacturing 2023-01-24 |
 PYRAMID 97693025 not registered Live/Pending |
Loud Labs, LLC 2022-11-27 |
 PYRAMID 97557401 not registered Live/Pending |
Echeverri Lopez Jose E 2022-08-21 |
 PYRAMID 88932667 not registered Live/Pending |
N15 Co., Ltd. 2020-05-26 |
 PYRAMID 88767087 not registered Live/Pending |
Inteplast Group Corporation 2020-01-21 |
 PYRAMID 88704230 not registered Live/Pending |
The Aloft Organization, LLC 2019-11-23 |
 PYRAMID 88607146 not registered Live/Pending |
Fanimation, Inc. 2019-09-06 |
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