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: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: Fracture Stem Screw FDA UDI
Model / Reference: PFX00028 FDA UDI
Description: Fracture Stem Screw FDA UDI

Identifiers

Catalog Number: PFX00028 FDA UDI
Primary DI / UDI-DI: 00846832093366 FDA UDI
FDA Product Code: HSD FDA UDI
KWT FDA UDI
KWS FDA UDI
PHX FDA UDI
PAO FDA UDI
GMDN Term: Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3690 FDA UDI
888.3650 FDA UDI
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

Dimensions & Sizes

Size: Length — 28 Millimeter FDA UDI

Category: Orthopaedic bone screw (non-sliding)

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

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

EVOS — Smith & Nephew, Inc. · Class II
TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Arthrex® — Arthrex, Inc. · Class II
Zavation — ZAVATION · Class II
STARDRIVE — Synthes GmbH · Class IIb
Arthrex® — Arthrex, Inc. · Class II
Cancellous Screw, Locking — I.T.S. GmbH · Class II
PANGEA — Stryker Corp. · 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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Tornier, Inc.

Sources (1)

FDA UDI a570db00-934c-43e0-b515-0eb612a06abf 36 fields · synced May 31, 2026