TIE-IN

Basic Information

• Brand Name: TIE-IN
• Primary DI: 00840420121844
• Version / Model: 8563003
• Catalog Number: 8563003
• Company Name: WRIGHT MEDICAL TECHNOLOGY, INC.
• Labeler DUNS: 807201207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-15
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 45c58db5-39b7-4caa-a883-ee8d2350fed1

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
KYI	PROSTHESIS, WRIST, CARPAL TRAPEZIUM	Orthopedic	888.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35663	Total wrist carpal articulation prosthesis	An implantable device designed to replace some of the carpal bone articulating surfaces 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 is implanted into hand bone distally; it 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	00840420121844	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size 3