Identity
- Trade Name
- Medtronic HV-R® Fenestrated Screw Cement FDA UDI
- Generic Name
- Orthopaedic cement, non-antimicrobial FDA UDI
- Device Name
- CEMENT 7480724T FENESTRATED SCRW PMMA US FDA UDI
- Model / Reference
- 7480724T FDA UDI
- Description
- CEMENT 7480724T FENESTRATED SCRW PMMA US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169715127 FDA UDI
- 510(k) Number
- K152604 FDA UDI
- FDA Product Code
- MNI FDA UDI
- GMDN Term
- Orthopaedic cement, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Category: Orthopaedic cement, non-antimicrobial
Medtronic HV-R® Fenestrated Screw Cement by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic cement, non-antimicrobial.
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Cleared under the same submission
K152604 also covers:
- CD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.
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
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 2d2191c4-3d6f-43af-b16f-597d92e5f64a 35 fields · synced Jun 7, 2026