DIPLOMAT AB0121-75065
GUDID 04047844020555
The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or more screws via the screw head and a rod using a force-fit or form-fit connection. Additional fixation elements, such as cross bars, hooks, connectors and washers, can also be used. The DIPLOMAT® pedicle screw system is applied temporarily to provide internal posterior stabilization until bone fusion in the lumbar or thoracic spine has taken place. The surgeon makes the final decision as to the indwelling time of the implant in the patient‘s body and the time when the implant is to be explanted. The pedicle screw system is implanted from a posterior approach. The implant is screwed into the vertebral body via the pedicle and it can be applied in a single segment or multiple segments. Implantation is facilitated by use of the specially developed accessories for inserting and positioning the implants. Only these accessories ensure safe use. Our product information provides further system-related information on the surgical method. If there are any preoperative uncertainties relating to the implant, information must be obtained from SIGNUS. Instruments specially developed by SIGNUS to ensure safe application are available for use with the implant system.
SIGNUS Medizintechnik GmbH
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 04047844020555 |
| NIH Device Record Key | 447d94a2-7660-4adf-96ac-c33db8644faa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIPLOMAT |
| Version Model Number | Pedicle screw, w/o tulip, polyaxial |
| Catalog Number | AB0121-75065 |
| Company DUNS | 344203948 |
| Company Name | SIGNUS Medizintechnik GmbH |
| 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 |
Customer Support Contacts
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com | |
| Phone | +49602391660 |
| info@signus.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04047844020555 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151704
FDA Product Code
| MNH | Orthosis, Spondylolisthesis Spinal Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
[04047844020555]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-09 |
| Device Publish Date | 2016-06-14 |
On-Brand Devices [DIPLOMAT]
| 04047844021910 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844021897 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844021873 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844021859 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844021835 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036617 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036600 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036594 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036587 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036570 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036563 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036556 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036549 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036532 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036525 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036518 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036501 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036495 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036488 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036471 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036464 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036457 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036440 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036433 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036426 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844036419 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844025130 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844025123 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844025116 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844025109 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844025093 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844025086 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844025079 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844025062 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844025055 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844025048 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844023778 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844022849 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844022832 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844022825 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844022818 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844022801 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844022795 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844022788 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844021811 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844021804 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844021781 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844021767 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844021743 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
| 04047844021736 | The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo |
Trademark Results [DIPLOMAT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIPLOMAT 97869695 not registered Live/Pending |
Hefter, Max 2023-04-03 |
 DIPLOMAT 97193297 not registered Live/Pending |
Steve Morgan 2021-12-28 |
 DIPLOMAT 87506498 5385479 Live/Registered |
Yuan, Quan 2017-06-27 |
 DIPLOMAT 87444425 5442048 Live/Registered |
Hearing Help Express, Inc. 2017-05-10 |
 DIPLOMAT 86867058 5556153 Live/Registered |
Abu AB 2016-01-06 |
 DIPLOMAT 86628403 4894710 Live/Registered |
SIGNUS Medizintechnik GmbH 2015-05-13 |
 DIPLOMAT 86619831 4925612 Live/Registered |
magFlags GmbH 2015-05-05 |
 DIPLOMAT 86478042 not registered Dead/Abandoned |
Abu Ab 2014-12-11 |
 DIPLOMAT 86441128 4759848 Live/Registered |
Hefter, Max 2014-10-31 |
 DIPLOMAT 86413904 not registered Dead/Abandoned |
Barberton Consultores e Serviços LDA. 2014-10-03 |
 DIPLOMAT 86295075 4802055 Live/Registered |
Alex's Meat Distributors, Corp. 2014-05-29 |
 DIPLOMAT 86051281 4510571 Live/Registered |
DipTech Systems, Inc. 2013-08-29 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.