Equinoxe

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Equinoxe FDA UDI
Generic Name: Shoulder prosthesis screw FDA UDI
Device Name: Low Profile Locking Cap FDA UDI
Model / Reference: 320-15-10 FDA UDI
Description: Low Profile Locking Cap FDA UDI

Identifiers

Catalog Number: 320-15-10 FDA UDI
Primary DI / UDI-DI: 10885862243997 FDA UDI
510(k) Number: K180632 FDA UDI
FDA Product Code: KWT FDA UDI
KWS FDA UDI
PHX FDA UDI
GMDN Term: Shoulder prosthesis screw FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3650 FDA UDI
888.3660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Shoulder prosthesis screw

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

Similar devices

Also classified as Shoulder prosthesis screw.

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COMPREHENSIVE SRS — Biomet Orthopedics, Inc. · Class II
COMPREHENSIVE REVERSE SHOULDER — Biomet Orthopedics, Inc. · Class II
Humelock II Cementless Shoulder System — FX SOLUTIONS · Class II
Titan™ — Ascension Orthopedics, Inc. · Class II
HemiCAP® — ARTHROSURFACE INCORPORATED · Class II
Titan™ — Ascension Orthopedics, Inc. · Class II
Comprehensive Reverse Shoulder — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

K180632 also covers:

Equinoxe — Exactech, Inc.

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 ec6de580-2da6-427d-8ad3-ac272a9bad4d 36 fields · synced May 31, 2026