AGILITY

Basic Information

• Brand Name: AGILITY
• Primary DI: 10603295035657
• Version / Model: 1404-32-000
• Catalog Number: 140432000
• Company Name: DEPUY ORTHOPAEDICS, INC.
• Labeler DUNS: 080506581
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ba842c47-633e-48eb-9438-f2755e3291d2

Device Description

AGILITY LP TOTAL ANKLE SYSTEM POLY INSERT SIZE 2

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
HSN	PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER	Orthopedic	888.3110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48180	Ankle prosthesis bearing	A sterile implantable device made of polyethylene (PE) designed to articulate the tibial and talar components of a total ankle prosthesis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10603295035657	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K053569	000
K122395	000