Latitude™ EV

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name: Latitude™ EV FDA UDI
Generic Name: Elbow radius prosthesis FDA UDI
Model / Reference: 0030523 FDA UDI

Identifiers

Catalog Number: 0030523 FDA UDI
Primary DI / UDI-DI: 00846832002900 FDA UDI
FDA Product Code: JDC FDA UDI
JDB FDA UDI
GMDN Term: Elbow radius prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3150 FDA UDI
888.3160 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

Dimensions & Sizes

Size: Length — 200 Millimeter FDA UDI

Category: Elbow radius prosthesis

Latitude™ EV by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Elbow radius prosthesis.

RHEAD — Stryker Corp. · Class II
Seitz Solution Radial Head — Kapp Surgical Instrument, Inc. · Class II
Seitz Solution Radial Head — Kapp Surgical Instrument, Inc. · Class II
Avenger — In2Bones, USA · Class II
Align — SKELETAL DYNAMICS L.L.C. · Class II
Seitz Solution Radial Head — Kapp Surgical Instrument, Inc. · Class II
L2L® — Zimmer, Inc. · Class II
RHEAD — 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

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Manufacturer

Manufacturer: Tornier, Inc.

Sources (1)

FDA UDI 1e2647da-c310-48fd-9fae-20e37fcd4c8c 35 fields · synced May 30, 2026