SMR Shoulder

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name: SMR Shoulder FDA UDI
Generic Name: Reverse shoulder head prosthesis trial FDA UDI
Device Name: Trial Glenosphere Dia.40mm FDA UDI
Model / Reference: Trial Glenosphere FDA UDI
Description: Trial Glenosphere Dia.40mm FDA UDI

Identifiers

Catalog Number: 9013.74.121 FDA UDI
Primary DI / UDI-DI: 08033390103435 FDA UDI
510(k) Number: K142139 FDA UDI
FDA Product Code: PHX FDA UDI
KWS FDA UDI
GMDN Term: Reverse shoulder head prosthesis trial 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

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Reverse shoulder head prosthesis trial

SMR Shoulder by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Reverse shoulder head prosthesis trial.

Equinoxe — Exactech, Inc. · Class I
AGILON® XO trial glenosphere — implantcast GmbH · Class II
AGILON® XO trial cap inverse — implantcast GmbH · Class II
Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
Comprehensive® Reverse Shoulder — Biomet Orthopedics, Inc. · Class II
REUNION — Stryker Corp. · Class II
Arthrex® — Arthrex, Inc. · Class II
Equinoxe — Exactech, Inc. · Class I

Cleared under the same submission

K142139 also covers:

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: Limacorporate

Sources (1)

FDA UDI 1d43d198-abaf-4115-a9f8-2f5644b046d2 36 fields · synced Jun 1, 2026