Equinoxe

Basic Information

• Brand Name: Equinoxe
• Primary DI: 10885862086396
• Version / Model: 320-01-42
• Catalog Number: 320-01-42
• Company Name: Exactech, Inc.
• Labeler DUNS: 157565946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-30
• Public Version: 4
• Public Version Date: 2019-08-28
• Public Version Status: Update
• Public Device Record Key: 89b9e65c-1c41-4a40-b81f-9f3fdc1f585b

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	888.3650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48093	Reverse shoulder prosthesis head	A sterile component of a reverse shoulder prosthesis that consists of a hemisphere-shaped metal or combined metal/polyethylene piece (glenosphere) intended to be attached to the reverse shoulder base plate, or directly to the glenoid fossa of the scapula, to articulate with the reverse shoulder cup.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10885862086396	GS1

Premarket Submissions

Submission Number	Supplement Number
K063569	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	42	Millimeter