ProMIS™ Fixation System
GUDID 07290115933291
Pre Bent Rod Ø6.0x340mm Blunt Edge The ProMIS Fixation System is designed to be implanted in the lumbar spine. The ProMIS Fixation System uses Polyaxial Head Pedicle Screws for fixation to the vertebrae.
PREMIA SPINE LTD
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 07290115933291 |
| NIH Device Record Key | bbe11218-a738-48b0-9659-33fbcd2a81df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProMIS™ Fixation System |
| Version Model Number | 87514 |
| 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 | true |
| 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 |
Device Dimensions
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 340 Millimeter |
| Outer Diameter | 6 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290115933291 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231844
FDA Product Code
| NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
[07290115933291]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-25 |
| Device Publish Date | 2024-01-17 |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.