Identity
- Trade Name
- KyphPak® First Fracture Tray FDA UDI
- Generic Name
- Balloon kyphoplasty kit FDA UDI
- Device Name
- KIT KEX202EB-CDS- 20/2 FF WITH CDS FDA UDI
- Model / Reference
- KEX202EB-CDS- FDA UDI
- Description
- KIT KEX202EB-CDS- 20/2 FF WITH CDS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169671669 FDA UDI
- 510(k) Number
- K103231 FDA UDI
- FDA Product Code
- HXG FDA UDIHRX FDA UDI
- GMDN Term
- Balloon kyphoplasty kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI888.1100 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
KyphPak® First Fracture Tray by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Balloon kyphoplasty kit.
- TRACKER — GS Medical Co., Ltd. · Class II
- Zavation — ZAVATION · Class I
- MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD. · Class II
- Zavation — ZAVATION · Class II
- KMC Double Balloon Assembly, 8 Gauge, 20mm — Shanghai Kinetic Medical Co., Ltd. · Class II
- Zavation — ZAVATION · Class II
- SYNTH™ PLUS — IMEDICOM CO., LTD. · Class II
- Zavation — ZAVATION · Class II
Cleared under the same submission
K103231 also covers:
- KYPHON® Inflation Syringe — MEDTRONIC SOFAMOR DANEK, INC.
- KyphPak® First Fracture Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KyphPak® First Fracture Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KyphPak® First Fracture Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KyphPak® First Fracture Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KyphPak® First Fracture Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KyphPak® First Fracture Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KyphPak® First Fracture Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KyphPak® First Fracture Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KyphPak® First Fracture Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KyphPak® First Fracture Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KyphPak® First Fracture Tray — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 524e2e30-e7ca-4173-89e4-dbc49e7c47d2 36 fields · synced May 29, 2026