Identity
- Trade Name
- MONOPOLY FDA UDI
- Generic Name
- Spinal bone set screw FDA UDI
- Device Name
- The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti-6AL-4V-Eli). FDA UDI
- Model / Reference
- Set screw FDA UDI
- Description
- The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti-6AL-4V-Eli). FDA UDI
Identifiers
- Catalog Number
- MP0140-0050 FDA UDI
- Primary DI / UDI-DI
- 04047844005194 FDA UDI
- FDA Product Code
- NKB FDA UDIKWP FDA UDIMNH FDA UDIMNI FDA UDI
- GMDN Term
- Spinal bone set screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal bone set screw
Monopoly by SIGNUS Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- SIGNUS Medizintechnik GmbH
Sources (1)
- FDA UDI 5451915c-74c8-49fd-94c8-418451c782ce 37 fields · synced May 31, 2026