DYNAMIS™ Implant System SI09545-S
GUDID 10810152101435
DYNAMIS™ SCREW DIA 9.5 X 45MM
PROMETHEAN RESTORATIVE LLC
Spinal bone screw, non-bioabsorbable| Primary Device ID | 10810152101435 |
| NIH Device Record Key | 6964f8bd-fca8-47cc-9c99-92e5cd3a172d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DYNAMIS™ Implant System |
| Version Model Number | SI09545-S |
| Catalog Number | SI09545-S |
| Company DUNS | 124592779 |
| Company Name | PROMETHEAN RESTORATIVE LLC |
| 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 |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 45 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10810152101435 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K243565
FDA Product Code
| OUR | Sacroiliac Joint Fixation |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-13 |
| Device Publish Date | 2025-03-05 |
On-Brand Devices [DYNAMIS™ Implant System]
| 10810152102005 | DYNAMIS™ SCREW DIA 13.5 X 90MM |
| 10810152101992 | DYNAMIS™ SCREW DIA 13.5 X 85MM |
| 10810152101985 | DYNAMIS™ SCREW DIA 13.5 X 80MM |
| 10810152101978 | DYNAMIS™ SCREW DIA 13.5 X 75MM |
| 10810152101961 | DYNAMIS™ SCREW DIA 13.5 X 70MM |
| 10810152101954 | DYNAMIS™ SCREW DIA 13.5 X 65MM |
| 10810152101947 | DYNAMIS™ SCREW DIA 13.5 X 60MM |
| 10810152101930 | DYNAMIS™ SCREW DIA 13.5 X 55MM |
| 10810152101923 | DYNAMIS™ SCREW DIA 13.5 X 50MM |
| 10810152101916 | DYNAMIS™ SCREW DIA 13.5 X 45MM |
| 10810152101909 | DYNAMIS™ SCREW DIA 13.5 X 40MM |
| 10810152101893 | DYNAMIS™ SCREW DIA 13.5 X 35MM |
| 10810152101886 | DYNAMIS™ SCREW DIA 12.5 X 90MM |
| 10810152101879 | DYNAMIS™ SCREW DIA 12.5 X 85MM |
| 10810152101862 | DYNAMIS™ SCREW DIA 12.5 X 80MM |
| 10810152101855 | DYNAMIS™ SCREW DIA 12.5 X 75MM |
| 10810152101848 | DYNAMIS™ SCREW DIA 12.5 X 70MM |
| 10810152101831 | DYNAMIS™ SCREW DIA 12.5 X 65MM |
| 10810152101824 | DYNAMIS™ SCREW DIA 12.5 X 60MM |
| 10810152101817 | DYNAMIS™ SCREW DIA 12.5 X 55MM |
| 10810152101800 | DYNAMIS™ SCREW DIA 12.5 X 50MM |
| 10810152101794 | DYNAMIS™ SCREW DIA 12.5 X 45MM |
| 10810152101787 | DYNAMIS™ SCREW DIA 12.5 X 40MM |
| 10810152101770 | DYNAMIS™ SCREW DIA 12.5 X 35MM |
| 10810152101763 | DYNAMIS™ SCREW DIA 11.5 X 90MM |
| 10810152101756 | DYNAMIS™ SCREW DIA 11.5 X 85MM |
| 10810152101749 | DYNAMIS™ SCREW DIA 11.5 X 80MM |
| 10810152101732 | DYNAMIS™ SCREW DIA 11.5 X 75MM |
| 10810152101725 | DYNAMIS™ SCREW DIA 11.5 X 70MM |
| 10810152101718 | DYNAMIS™ SCREW DIA 11.5 X 65MM |
| 10810152101701 | DYNAMIS™ SCREW DIA 11.5 X 60MM |
| 10810152101695 | DYNAMIS™ SCREW DIA 11.5 X 55MM |
| 10810152101688 | DYNAMIS™ SCREW DIA 11.5 X 50MM |
| 10810152101671 | DYNAMIS™ SCREW DIA 11.5 X 45MM |
| 10810152101664 | DYNAMIS™ SCREW DIA 11.5 X 40MM |
| 10810152101657 | DYNAMIS™ SCREW DIA 11.5 X 35MM |
| 10810152101640 | DYNAMIS™ SCREW DIA 10.5 X 90MM |
| 10810152101633 | DYNAMIS™ SCREW DIA 10.5 X 85MM |
| 10810152101626 | DYNAMIS™ SCREW DIA 10.5 X 80MM |
| 10810152101619 | DYNAMIS™ SCREW DIA 10.5 X 75MM |
| 10810152101602 | DYNAMIS™ SCREW DIA 10.5 X 70MM |
| 10810152101596 | DYNAMIS™ SCREW DIA 10.5 X 65MM |
| 10810152101589 | DYNAMIS™ SCREW DIA 10.5 X 60MM |
| 10810152101572 | DYNAMIS™ SCREW DIA 10.5 X 55MM |
| 10810152101565 | DYNAMIS™ SCREW DIA 10.5 X 50MM |
| 10810152101558 | DYNAMIS™ SCREW DIA 10.5 X 45MM |
| 10810152101541 | DYNAMIS™ SCREW DIA 10.5 X 40MM |
| 10810152101534 | DYNAMIS™ SCREW DIA 10.5 X 35MM |
| 10810152101527 | DYNAMIS™ SCREW DIA 9.5 X 90MM |
| 10810152101510 | DYNAMIS™ SCREW DIA 9.5 X 85MM |
Trademark Results [DYNAMIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DYNAMIS 98569870 not registered Live/Pending |
LEM Surgical AG 2024-05-27 |
 DYNAMIS 98537917 not registered Live/Pending |
DYNAMIS COUNSELING LLC 2024-05-07 |
 DYNAMIS 98393606 not registered Live/Pending |
Promethean Restorative, LLC 2024-02-06 |
 DYNAMIS 90471958 not registered Live/Pending |
HENRY & CO. GROUP CORP. 2021-01-18 |
 DYNAMIS 88411396 not registered Live/Pending |
Highland Vineyards LLC 2019-05-01 |
 DYNAMIS 87658176 not registered Live/Pending |
Dynamis, Inc. 2017-10-24 |
 DYNAMIS 87655949 not registered Live/Pending |
Dynamis, Inc. 2017-10-23 |
 DYNAMIS 87652126 not registered Live/Pending |
Dynamis, Inc. 2017-10-19 |
 DYNAMIS 87489207 5522405 Live/Registered |
Dynamis LLC 2017-06-14 |
 DYNAMIS 87160062 not registered Dead/Abandoned |
Greymatter Alliance, Inc. 2016-09-02 |
 DYNAMIS 86736074 not registered Dead/Abandoned |
Davis, Joshua 2015-08-25 |
 DYNAMIS 86302395 4791739 Live/Registered |
Life Technologies Corporation 2014-06-06 |
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