Equinoxe

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Equinoxe FDA UDI
Generic Name: Bone-resection orthopaedic reamer, reusable FDA UDI
Model / Reference: SPI-038814 FDA UDI

Identifiers

Catalog Number: SPI-038814 FDA UDI
Primary DI / UDI-DI: 10885862596079 FDA UDI
510(k) Number: K063569 FDA UDI
K073688 FDA UDI
K082702 FDA UDI
K093275 FDA UDI
K101909 FDA UDI
K102951 FDA UDI
K110708 FDA UDI
K131575 FDA UDI
K150458 FDA UDI
K193098 FDA UDI
FDA Product Code: PHX FDA UDI
KWS FDA UDI
KWT FDA UDI
GMDN Term: Bone-resection orthopaedic reamer, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
888.3650 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: Bone-resection orthopaedic reamer, reusable

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

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Cleared under the same submission

K063569 also covers:

K073688 also covers:

K082702 also covers:

K093275 also covers:

K101909 also covers:

K102951 also covers:

K110708 also covers:

K131575 also covers:

K150458 also covers:

Equinoxe — Exactech, Inc.
Equinoxe — Exactech, Inc.

K193098 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: Exactech, Inc.

Sources (1)

FDA UDI 0afa6414-19be-46ce-9595-685c2b217e22 34 fields · synced May 30, 2026