Identity
- Trade Name
- MONOPOLY VC FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable 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
- Pedicle screw, cannulated, polyaxial 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
- MP0220-6530 FDA UDI
- Primary DI / UDI-DI
- 04047844006146 FDA UDI
- 510(k) Number
- K092073 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDIKWP FDA UDINKB FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable 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 screw, non-bioabsorbable
Monopoly Vc by SIGNUS Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal bone screw, non-bioabsorbable.
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Cleared under the same submission
K092073 also covers:
- MONOPOLY VC — SIGNUS Medizintechnik GmbH
- MONOPOLY VC — SIGNUS Medizintechnik GmbH
- MONOPOLY VC — SIGNUS Medizintechnik GmbH
- MONOPOLY VC — SIGNUS Medizintechnik GmbH
- MONOPOLY VC — SIGNUS Medizintechnik GmbH
- MONOPOLY VC — SIGNUS Medizintechnik GmbH
- MONOPOLY VC — SIGNUS Medizintechnik GmbH
- MONOPOLY VC — SIGNUS Medizintechnik GmbH
- MONOPOLY VC — SIGNUS Medizintechnik GmbH
- MONOPOLY VC — SIGNUS Medizintechnik GmbH
- MONOPOLY VC — SIGNUS Medizintechnik GmbH
- MONOPOLY VC — SIGNUS Medizintechnik GmbH
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 cf56334a-5376-4455-9211-3ccd0a7dacf4 38 fields · synced Jun 8, 2026