Equinoxe

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Equinoxe FDA UDI
Generic Name: Orthopaedic broach FDA UDI
Device Name: Special Preserve Stem 10mm Extended Broach FDA UDI
Model / Reference: SPI-005669 FDA UDI
Description: Special Preserve Stem 10mm Extended Broach FDA UDI

Identifiers

Catalog Number: SPI-005669 FDA UDI
Primary DI / UDI-DI: 10885862633415 FDA UDI
FDA Product Code: HSD FDA UDI
KWT FDA UDI
KWS FDA UDI
PHX FDA UDI
GMDN Term: Orthopaedic broach FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3690 FDA UDI
888.3650 FDA UDI
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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic broach

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

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TEMA Elbow — Limacorporate · Class II
APEX Knee System — OMNIlife science, Inc. · Class I

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: Exactech, Inc.

Sources (1)

FDA UDI beefc656-92ca-4e78-971a-4c5c46e6f460 34 fields · synced Jun 1, 2026