Medtronic Reusable Instruments

FDA UDI

Class I (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: Medtronic Reusable Instruments FDA UDI
Generic Name: Orthopaedic fixation implant alignment tool FDA UDI
Device Name: HEAD POSITIONER EX0912103 6.35MM MAS FDA UDI
Model / Reference: EX0912103 FDA UDI
Description: HEAD POSITIONER EX0912103 6.35MM MAS FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169278387 FDA UDI
FDA Product Code: KIL FDA UDI
LXH FDA UDI
GMDN Term: Orthopaedic fixation implant alignment tool 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

FDA UDI

Single Use

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic fixation implant alignment tool

Medtronic Reusable Instruments by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Flux-C Cervical Interbody — ULRICH MEDICAL USA, INC. · Class II
Easyspine — Ldr Spine USA · Class I

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 5bae6a58-025c-4284-bfac-310e90651485 34 fields · synced May 29, 2026