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: Humeral body extension prosthesis FDA UDI
Device Name: Fracture Humeral Spacer FDA UDI
Model / Reference: PFX00011 FDA UDI
Description: Fracture Humeral Spacer FDA UDI

Identifiers

Catalog Number: PFX00011 FDA UDI
Primary DI / UDI-DI: 00846832092567 FDA UDI
FDA Product Code: PHX FDA UDI
PAO FDA UDI
GMDN Term: Humeral body extension prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Humeral body extension prosthesis

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

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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 e5f7a8e2-8320-44ff-8acf-943d513058e7 36 fields · synced May 30, 2026