ProMIS™ Fixation System
GUDID 07290014381025
Straight Rod Ø6.0x300mm Hex Edge
PREMIA SPINE LTD
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 07290014381025 |
| NIH Device Record Key | 839c70d0-fd40-42de-88df-0d0276651476 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProMIS™ Fixation System |
| Version Model Number | 87344 |
| Company DUNS | 649220779 |
| Company Name | PREMIA SPINE LTD |
| 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 | false |
| OTC Over-The-Counter | false |
Device Dimensions
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 6 Millimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290014381025 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150380
FDA Product Code
| MNH | Orthosis, Spondylolisthesis Spinal Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
[07290014381025]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-11 |
| Device Publish Date | 2018-06-10 |
On-Brand Devices [ProMIS™ Fixation System]
| 07290014381025 | Straight Rod Ø6.0x300mm Hex Edge |
| 07290014381018 | Straight Rod Ø6.0x250mm Hex Edge |
| 07290014080324 | Pre-Bent Rod Ø6.0x35mm R128 Hex Edge |
| 07290014080294 | Pre-Bent Rod Ø6.0x75mm R128 Hex Edge |
| 07290014080287 | Pre-Bent Rod Ø6.0x65mm R128 Hex Edge |
| 07290014080270 | Pre-Bent Rod Ø6.0x55mm R128 Hex Edge |
| 07290014080263 | Pre-Bent Rod Ø6.0x45mm R128 Hex Edge |
| 07290014080089 | Pre-Bent Rod Ø6.0x150mm R128 Hex Edge |
| 07290014080072 | Pre-Bent Rod Ø6.0x140mm R128 Hex Edge |
| 07290014080065 | Pre-Bent Rod Ø6.0x130mm R128 Hex Edge |
| 07290014080058 | Pre-Bent Rod Ø6.0x120mm R128 Hex Edge |
| 07290014080041 | Pre-Bent Rod 6.0x110mm R128 Hex Edge |
| 07290014080034 | Pre-Bent Rod Ø6.0x100mm R128 Hex Edge |
| 07290014080027 | Pre-Bent Rod Ø6.0x90mm R128 Hex Edge |
| 07290014080010 | Pre-Bent Rod Ø6.0x80mm R128 Hex Edge |
| 07290014080003 | Pre-Bent Rod Ø6.0x70mm R128 Hex Edge |
| 07290014064997 | Pre-Bent Rod Ø6.0x60mm R128 Hex Edge |
| 07290014064980 | Pre-Bent Rod Ø6.0x50mm R128 Hex Edge |
| 07290014064973 | Pre-Bent Rod Ø6.0x40mm R128 Hex Edge |
| 07290115933932 | Pre Bent Rod Ø6.0x35mm Hex edge. The ProMIS Fixation System is designed to be implanted in the |
| 07290115934069 | Pre Bent Rod Ø6.0x100mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115934052 | Pre Bent Rod Ø6.0x95mm Hex Edge The ProMIS Fixation System is designed to be implanted in the l |
| 07290115934045 | Pre Bent Rod Ø6.0x90mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115934038 | Pre Bent Rod Ø6.0x85mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115934021 | Pre Bent Rod Ø6.0x80mm Hex Edge The ProMIS Fixation System is designed to be implanted in the l |
| 07290115934014 | Pre Bent Rod Ø6.0x75mm Hex Edge The ProMIS Fixation System is designed to be implanted in the l |
| 07290115934007 | Pre Bent Rod Ø6.0x70mm Hex Edge The ProMIS Fixation System is designed to be implanted in the l |
| 07290115933994 | Pre Bent Rod Ø6.0x65mm Hex Edge The ProMIS Fixation System is designed to be implanted in the l |
| 07290115933987 | Pre Bent Rod Ø6.0x60mm Hex Edge The ProMIS Fixation System is designed to be implanted in the l |
| 07290115933970 | Pre Bent Rod Ø6.0x55mm Hex Edge The ProMIS Fixation System is designed to be implanted in the l |
| 07290115933963 | Pre Bent Rod Ø6.0x50mm Hex Edge The ProMIS Fixation System is designed to be implanted in the l |
| 07290115933956 | Pre Bent Rod Ø6.0x45mm Hex Edge The ProMIS Fixation System is designed to be implanted in the l |
| 07290115933949 | Pre Bent Rod Ø6.0x40mm Hex edge. The ProMIS Fixation System is designed to be implanted in the |
| 07290115933659 | Straight Rod Ø6.0x340mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933642 | Straight Rod Ø6.0x270mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933635 | Straight Rod Ø6.0x220mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933628 | Straight Rod Ø6.0x210mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933611 | Straight Rod Ø6.0x200mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933604 | Straight Rod Ø6.0x190mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933598 | Straight Rod Ø6.0x180mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933581 | Straight Rod Ø6.0x175mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933574 | Straight Rod Ø6.0x170mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933567 | Straight Rod Ø6.0x165mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933550 | Straight Rod Ø6.0x160mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933543 | Straight Rod Ø6.0x155mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933536 | Straight Rod Ø6.0x150mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933529 | Straight Rod Ø6.0x145mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933512 | Straight Rod Ø6.0x140mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933505 | Straight Rod Ø6.0x135mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
| 07290115933499 | Straight Rod Ø6.0x130mm Hex Edge The ProMIS Fixation System is designed to be implanted in the |
Trademark Results [ProMIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROMIS 97059802 not registered Live/Pending |
Quanta Technology, LLC 2021-10-05 |
 PROMIS 86915135 not registered Dead/Abandoned |
S&K Aerospace llc 2016-02-22 |
 PROMIS 86494492 4878577 Live/Registered |
Promis, LLC 2015-01-02 |
 PROMIS 85762740 4495812 Live/Registered |
OREGON GLOBAL DISTRIBUTION, INC. 2012-10-24 |
 PROMIS 85045164 3900510 Dead/Cancelled |
AUSTIN BUILDING AND DESIGN INC. 2010-05-21 |
 PROMIS 79157752 4741475 Live/Registered |
PREMIA SPINE LTD 2014-09-10 |
 PROMIS 78026150 2691751 Dead/Cancelled |
AUSTIN BUILDING AND DESIGN INC. 2000-09-15 |
 PROMIS 77321399 3677184 Live/Registered |
U.S. Department of Health and Human Services 2007-11-05 |
 PROMIS 77307252 3677151 Live/Registered |
U.S. Department of Health and Human Services 2007-10-18 |
 PROMIS 76334758 not registered Dead/Abandoned |
NUCLEUS TECHNOLOGIES LLC, 2001-11-06 |
 PROMIS 76306160 2651613 Dead/Cancelled |
NUCLEUS TECHNOLOGIES LLC 2001-08-28 |
 PROMIS 73557024 1397614 Dead/Cancelled |
CROSS, HAROLD D. 1985-09-06 |
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