Identity
- Trade Name
- Express™ Osteo Introducer® System; CDS and BFD FDA UDI
- Generic Name
- Balloon kyphoplasty kit FDA UDI
- Device Name
- KIT KEX102EB-CDS-A 10/2 FF W CDS FDA UDI
- Model / Reference
- KEX102EB-CDS-A FDA UDI
- Description
- KIT KEX102EB-CDS-A 10/2 FF W CDS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000557089 FDA UDI
- 510(k) Number
- K123771 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Balloon kyphoplasty kit FDA UDI
- Models / Variants
- CDS and BFD 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
Express™ Osteo Introducer® System +1 more model by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — 2 models
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
K123771 also covers:
- Express™ Osteo Introducer® System; CDS and BFD — MEDTRONIC SOFAMOR DANEK, INC.
- Express™ Osteo Introducer® System; CDS and BFD — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Express II Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Express II Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Express II Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Express II KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Express II KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Express II KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Express II KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Express II KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON Express II KyphoPak Tray — MEDTRONIC SOFAMOR DANEK, INC.
- KYPHON® Express™ II 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 e61979d1-ee39-45dc-92a3-e65e185fe182 36 fields · synced Jun 8, 2026