Identity
- Trade Name
- KYPHON Express KyphoPak Tray FDA UDI
- Generic Name
- Balloon kyphoplasty kit FDA UDI
- Device Name
- KIT KPE1001 KYPAK EXP TRY 10/2 FF W/EOIS FDA UDI
- Model / Reference
- KPE1001 FDA UDI
- Description
- KIT KPE1001 KYPAK EXP TRY 10/2 FF W/EOIS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000031800 FDA UDI
- 510(k) Number
- K041454 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Balloon kyphoplasty kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
No
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: Balloon kyphoplasty kit
KYPHON Express KyphoPak Tray by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Balloon kyphoplasty kit.
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Cleared under the same submission
K041454 also covers:
- BALLOON KYPHOPLASTY ESSENTIALS — MEDTRONIC SOFAMOR DANEK, INC.
- BALLOON KYPHOPLASTY ESSENTIALS — MEDTRONIC SOFAMOR DANEK, INC.
- Balloon Kyphoplasty Essentials Kit — MEDTRONIC SOFAMOR DANEK, INC.
- Balloon Kyphoplasty Essentials Kit — MEDTRONIC SOFAMOR DANEK, INC.
- InflateFX® Gen II Fracture Management — MEDTRONIC SOFAMOR DANEK, INC.
- InflateFX™ Gen II Fracture Management — MEDTRONIC SOFAMOR DANEK, INC.
- InflateFX™ Gen II Fracture Management — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Express Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Express Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Express KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Express KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Xpander Inflatable Bone Tamp — 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 ef1a2adc-d66b-46f0-9be9-553d5cf5258a 36 fields · synced May 30, 2026