DIPLOMAT MIS
- Primary DI
- 04047844033777
- Brand
- DIPLOMAT MIS
- Company
- SIGNUS Medizintechnik GmbH
- Model
- Rod, straight
- Catalog number
- AB0655-00110/S
- Device description
- 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.
- Published
- 2019-10-29
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K151704 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04047844033777 | Package | GS1 | 2 | In Commercial Distribution |
| 04047844033760 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04047844033777 | 04047844033777 | 4047844033777 |
| 04047844033760 | 04047844033760 | 4047844033760 |
GMDN Terms#
| Term | Definition |
|---|---|
| Bone-screw internal spinal fixation system, sterile | An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 0 Degrees Celsius | 35 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +49602391660 | info@signus.com |
Regulatory Flags#
- DUNS number
- 344203948
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04047844129241 | DIPLOMAT | Threaded awl cannulated, obturator | AC0088 | 2026-05-20 |
| 04047844129258 | DIPLOMAT | Threaded awl cannulated, obturator | AC0089 | 2026-05-20 |
| 04047844102596 | COSY | Cross connector | CA0155-38048/S | 2023-03-21 |
| 04047844102602 | COSY | Cross connector | CA0155-44052/S | 2023-03-21 |
| 04047844098479 | COSY | Retaining nut tulips cross connector | CA0160-00200 | 2023-03-15 |
| 04047844127063 | COSY | Tray, lid | CB03AY-LID-1 | 2026-04-22 |
| 04047844098707 | COSY | Occiput plate | CA0005-32056 | 2023-03-15 |
| 04047844116432 | COSY | Obturatorwire | CB0101-3 | 2023-03-15 |
| 04047844116449 | COSY | Guide wire, round/round | CB0144 | 2023-03-15 |
| 04047844129272 | INSTRUMENT | Tray, instruments | P009AY | 2026-02-11 |
| 04047844129289 | INSTRUMENT | Tray, insert, instruments | P009AZ | 2026-02-11 |
| 04047844129296 | COSY | Tray, implants | CA01AY | 2026-02-11 |
| 04047844129302 | COSY | Tray, insert, implants | CA01AZ | 2026-02-11 |
| 04047844129319 | COSY | Tray, implants | CA02AY | 2026-02-11 |
| 04047844129326 | COSY | Rack, screws | CA1235AZ | 2026-02-11 |
| 04047844129333 | COSY | Rack, screws | CA1240AZ | 2026-02-11 |
| 04047844129340 | COSY | Rack, screws | CA1245AZ | 2026-02-11 |
| 04047844129357 | COSY | Rack, shank screws | CA1735AZ | 2026-02-11 |
| 04047844129364 | COSY | Rack, shank screws | CA1740AZ | 2026-02-11 |
| 04047844129371 | COSY | Rack, screws angled | CA3235AZ | 2026-02-11 |
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