MAESTRO TOTAL WRIST

Basic Information

• Brand Name: MAESTRO TOTAL WRIST
• Primary DI: 00880304470293
• Version / Model: 180413
• Catalog Number: 180413
• Company Name: Biomet Orthopedics, LLC
• Labeler DUNS: 129278169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 621157b2-2f6a-4a6f-badb-983c8257dd78

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: No
• 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
JWJ	PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED	Orthopedic	888.3800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33370	Total wrist radius prosthesis	An implantable device designed to replace the distal end of the radius as part of a total wrist replacement, typically to treat severe bone fracture or degenerative disease (e.g., arthritis). It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and consists of a stem and articulating surface, and may interface with a spacer. Fixation devices for implantation (e.g., screws) may be included with the prosthesis and implantation may be performed with or without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00880304470293	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K080426	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			SIZE 1 12MM HEIGHT