Equinoxe

FDA UDI

Class I (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Equinoxe FDA UDI
Generic Name: Reverse shoulder head prosthesis trial FDA UDI
Device Name: GLENOSPHERE TRIAL 46MM FDA UDI
Model / Reference: 321-06-46 FDA UDI
Description: GLENOSPHERE TRIAL 46MM FDA UDI

Identifiers

Catalog Number: 321-06-46 FDA UDI
Primary DI / UDI-DI: 10885862558886 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Reverse shoulder head prosthesis trial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 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

Yes

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

Dimensions & Sizes

Size: Outer Diameter — 46 Millimeter FDA UDI

Category: Reverse shoulder head prosthesis trial

Equinoxe by Exactech, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Reverse shoulder head prosthesis trial.

ProMade Shoulder — Limacorporate · 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
SMR Shoulder - Hybrid Glenoid — Limacorporate · Class II
REUNION — Stryker Corp. · Class II
Arthrex® — Arthrex, 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 I	Pending data

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

Manufacturer

Manufacturer: Exactech, Inc.

Sources (1)

FDA UDI 2525f228-7868-4c1f-89a6-c719823d1970 35 fields · synced May 30, 2026