SACRONAIL
- Primary DI
- 04047844122099
- Brand
- SACRONAIL
- Company
- SIGNUS Medizintechnik GmbH
- Model
- Length indicator
- Catalog number
- PBZ0017-A
- Device description
- The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage. The implant consists of a nail of various lengths from135mm to 194mm with a constant diameter of 8mm and 2 locking screws in different lengths. This variation ensures adaptation to the respective anatomy of the patient. The intersections of the screw axes to the implant axis have a distance of 15mm to the respective end face of the nail. This ensures a solid support on the lateral cortex of the Ilia. The angle of the screw axes to the implant axis corresponds to the anatomical conditions and is 70°. The locking screw ensures a stable connection of the components. The tips of the locking screws are rounded to facilitate insertion into the nail while the dorsal ends of locking screws are a hexagon. The caps serve to close the instrument connection of the nail. The implants are made from the Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488. There are Instruments which are specific to the implantation of the SACRONAIL device. These include, but are not limited to, the Guide Frame, the Guide Bracket, the Fixation Bracket, various Instrument Guides, various dilators and drills, screwdrivers as well as the specific tools for revision of the device.
- Published
- 2024-06-05
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Contact Domains
Product Codes
| Code | Name |
|---|---|
| LXH | Orthopedic Manual Surgical Instrument |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04047844122099 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04047844122099 | 04047844122099 | 4047844122099 |
GMDN Terms
| Term | Definition |
|---|---|
| Orthopaedic surgical procedure kit, non-medicated, reusable | A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 0 Degrees Celsius | 35 Degrees Celsius |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | |
|---|---|
| +49602391660 | info@signus.com |
Regulatory Flags
- DUNS number
- 344203948
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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|---|---|---|---|---|
| 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 |
| 04047844129388 | COSY | Rack, screws angled | CA3240AZ | 2026-02-11 |
| 04047844129395 | COSY | Rack, set screws | CA0140AZ | 2026-02-11 |
| 04047844129401 | COSY | Rack, set screws, connectors | CA0150AZ | 2026-02-11 |
| 04047844130124 | INSTRUMENT | Lamina Spreader | SN0027 | 2026-01-19 |
| 04047844122860 | CYLOX ST 12° | Cervical cage integrated, stand alone, angled | CYS12061512 | 2025-09-11 |
| 04047844122877 | CYLOX ST 12° | Cervical cage integrated, stand alone, angled | CYS12071512 | 2025-09-11 |
| 04047844122884 | CYLOX ST 12° | Cervical cage integrated, stand alone, angled | CYS12081512 | 2025-09-11 |
| 04047844122891 | CYLOX ST 12° | Cervical cage integrated, stand alone, angled | CYS12091512 | 2025-09-11 |
| 04047844122907 | CYLOX ST 12° | Cervical cage integrated, stand alone, angled | CYS12101512 | 2025-09-11 |
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