FDA UDI
In Commercial Distribution
🇺🇸 United States
MONOPOLY/CONKLUSION
DI: 04047844039953
·
Model: Locking plate
·
SIGNUS Medizintechnik GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MONOPOLY/CONKLUSION
- Primary DI
- 04047844039953
- Version / Model
- Locking plate
- Catalog Number
- 150510
- Company Name
- SIGNUS Medizintechnik GmbH
- Labeler DUNS
- 344203948
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 5
- Public Version Date
- 2025-07-14
- Public Version Status
- Update
- Public Device Record Key
- 7118db82-7386-4906-8440-dba1509272d4
Device Description
The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, screws, rods, connectors, and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using posterior approach.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | 888.3070 | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65553 | Spinal bone set screw | A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04047844039953 | GS1 |
Customer Contacts
- Phone
- +49602391660
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 35 Degrees Celsius