Identity
- Trade Name
- KYPHON Xpander II KyphoPak Tray FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- BONE TAMP KIT KPX153NB AF X2 15/3 FDA UDI
- Model / Reference
- KPX153NB FDA UDI
- Description
- BONE TAMP KIT KPX153NB AF X2 15/3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000027018 FDA UDI
- 510(k) Number
- K101864 FDA UDI
- FDA Product Code
- HXG FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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: Instrument tray, reusable
KYPHON Xpander II KyphoPak Tray by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Instrument tray, reusable.
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
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 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 38e91ac3-8e75-4bcc-8599-21dc591c8380 36 fields · synced Jun 8, 2026