Shoulder iD

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name: Shoulder iD FDA UDI
Generic Name: Reverse shoulder prosthesis base plate FDA UDI
Device Name: Primary Reversed Glenoid FDA UDI
Model / Reference: DWJ608 FDA UDI
Description: Primary Reversed Glenoid FDA UDI

Identifiers

Catalog Number: DWJ608 FDA UDI
Primary DI / UDI-DI: 00840338604231 FDA UDI
FDA Product Code: PHX FDA UDI
KWS FDA UDI
GMDN Term: Reverse shoulder prosthesis base plate 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 29 Millimeter FDA UDI
Length — 35 Millimeter FDA UDI

Category: Reverse shoulder prosthesis base plate

Shoulder iD by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Reverse shoulder prosthesis base plate.

AGILON® XO glenoid cementless cpTi — implantcast GmbH · Class II
Glenoid Reconstruction System — Medacta International · Class II
Titan™ — Ascension Orthopedics, Inc. · Class II
REUNION — Stryker Corp. · Class II
Delta Xtend — DEPUY (IRELAND) · Class II
Arthrex® — Arthrex, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II
Titan Reverse Shoulder System — Smith & Nephew, 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 f8c6fef2-e27b-468e-8f25-27271f8a2678 36 fields · synced May 29, 2026