Tornier Perform Humeral System

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name: Tornier Perform Humeral System FDA UDI
Generic Name: Medullary canal orthopaedic reamer, rigid FDA UDI
Device Name: Fracture Stem Reamer FDA UDI
Model / Reference: IFX08 FDA UDI
Description: Fracture Stem Reamer FDA UDI

Identifiers

Catalog Number: IFX08 FDA UDI
Primary DI / UDI-DI: 00846832085873 FDA UDI
FDA Product Code: KWT FDA UDI
GMDN Term: Medullary canal orthopaedic reamer, rigid FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3650 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Medullary canal orthopaedic reamer, rigid

Tornier Perform Humeral System by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Medullary canal orthopaedic reamer, rigid.

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Panta® 2 — Ascension Orthopedics, Inc. · Class I
Legion — Smith & Nephew, Inc. · Class II
INSTRUMENT — Howmedica Osteonics Corp. · 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 II	Pending data

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Manufacturer

Manufacturer: Tornier, Inc.

Sources (1)

FDA UDI d8e46347-6c79-459e-a8de-ebf6b7fb8281 36 fields · synced Jun 1, 2026