Identity
- Trade Name
- Kyphon ELEMENT Bone Filler Device FDA UDI
- Generic Name
- Orthopaedic cement dispenser FDA UDI
- Device Name
- BONE FILLER 7480703T BFD SIZE 3 FDA UDI
- Model / Reference
- 7480703T FDA UDI
- Description
- BONE FILLER 7480703T BFD SIZE 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000026707 FDA UDI
- FDA Product Code
- KIH FDA UDI
- GMDN Term
- Orthopaedic cement dispenser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
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 dispenser
Kyphon ELEMENT Bone Filler Device by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement dispenser.
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- Vertebra Filler Device (Frontal Opening) — Joline GmbH & Co. KG · Class II
- VertePort X4 Manifold — Stryker Corp. · Class I
- Graftgun Universal Graft Delivery System - Narrow Tip Adapter — SURGENTEC LLC · Class II
- Neo Medical Pedicle Screw System — Neo Medical Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 246c900f-eb03-4998-aa8d-61a04c3ec357 35 fields · synced May 30, 2026