AEQUALIS™ PerFORM+ Reversed

Basic Information

• Brand Name: AEQUALIS™ PerFORM+ Reversed
• Primary DI: 00846832062058
• Version / Model: DWJ515
• Company Name: TORNIER, INC.
• Labeler DUNS: 968990812
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 86b5173d-a3cc-4dc3-9b20-0f402447f7da

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	Orthopedic	888.3660	2
PHX	shoulder prosthesis, reverse configuration	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48091	Reverse shoulder prosthesis base plate	A sterile component of a reverse shoulder prosthesis that consists of a metal plate [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] intended to be firmly attached to the scapula with screws. It is intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00846832062058	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K161742	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	29	Millimeter
Angle	15	degree