KYPHON® Introducer Tool Kit

FDA UDI

Class I (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: KYPHON® Introducer Tool Kit FDA UDI
Generic Name: Bone access channel kit FDA UDI
Device Name: KIT T01A INTRODUCER TOOL KIT SIZE 3 FDA UDI
Model / Reference: T01A FDA UDI
Description: KIT T01A INTRODUCER TOOL KIT SIZE 3 FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169097278 FDA UDI
FDA Product Code: FZX FDA UDI
GDI FDA UDI
GEA FDA UDI
HTW FDA UDI
GMDN Term: Bone access channel kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Bone access channel kit

KYPHON® Introducer Tool Kit by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone access channel kit.

Keyfix bone drill 9G — G21 SRL · Class I
KMC Vertebral Osteotome — Shanghai Kinetic Medical Co., Ltd. · Class I
Osseoflex® — Merit Medical Systems, Inc. · Class I
Drill — Shanghai Kinetic Medical Co., Ltd. · Class II
0.035" x 5" K-Wire Standard — Trilliant Surgical LLC · Class II
Cannula — Shanghai Kinetic Medical Co., Ltd. · Class II
Multifunctional Tool — Shanghai Kinetic Medical Co., Ltd. · Class II
KMC Guide Wire, 1.6mm, Sharp Tip — Shanghai Kinetic Medical Co., Ltd. · Class II

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

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Manufacturer

Manufacturer: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI 5480f157-9d4c-499b-b8ab-1191be249ad9 34 fields · synced May 30, 2026