Latitude™ - Elbow

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name: Latitude™ - Elbow FDA UDI
Generic Name: Hinged total elbow prosthesis FDA UDI
Model / Reference: DKY204 FDA UDI

Identifiers

Catalog Number: DKY204 FDA UDI
Primary DI / UDI-DI: 00846832011063 FDA UDI
FDA Product Code: JDC FDA UDI
JDB FDA UDI
GMDN Term: Hinged total elbow 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

Category: Hinged total elbow prosthesis

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

Similar devices

Also classified as Hinged total elbow prosthesis.

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SORBIE QUESTOR — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
BI-AXIAL™ ELBOW SYSTEM — Biomet Orthopedics, Inc. · Class II
Nexel" — Zimmer, Inc. · Class II
Nexel" — Zimmer, Inc. · Class II
Nexel" — Zimmer, Inc. · Class II
SORBIE QUESTOR ™ — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Nexel" — Zimmer, Inc. · 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 927585b5-446b-48ba-8676-c96a733a4e60 35 fields · synced May 31, 2026