Identity
- Trade Name
- KYPHON® Osteo Introducer® System and BFD FDA UDI
- Generic Name
- Balloon kyphoplasty kit FDA UDI
- Device Name
- IBT KIT KPX153RB-A FF X2 15/3 OIS FDA UDI
- Model / Reference
- KPX153RB-A FDA UDI
- Description
- IBT KIT KPX153RB-A FF X2 15/3 OIS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000557713 FDA UDI
- 510(k) Number
- K101864 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
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: Balloon kyphoplasty kit
KYPHON® Osteo Introducer® System and BFD by Medtronic Sofamor Danek, Inc. — Class II — 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
K101864 also covers:
- KYPHON Xpander II Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Xpander II Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Xpander II Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Xpander II KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Xpander II KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Xpander II KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Xpander II KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Xpander II KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Xpander II KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Xpander II KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Xpander II KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Xpander II KyphoPak 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI b3b9e38e-e77b-4a09-a3ef-1219f99ade6e 36 fields · synced Jun 6, 2026