Titan™

Basic Information

• Brand Name: Titan™
• Primary DI: 10381780467601
• Version / Model: LNR-0960-192-9R
• Catalog Number: LNR-0960-192-9R
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-09
• Public Version: 2
• Public Version Date: 2023-01-25
• Public Version Status: Update
• Public Device Record Key: 4df23697-440c-428d-a463-e4cb40879c32
• Distribution End Date: 2026-12-31

Device Description

RSS HXL Liner Retentive, +9R

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PHX	shoulder prosthesis, reverse configuration	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48092	Polyethylene reverse shoulder prosthesis cup	A sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780467601	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K190588	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			9R
Device Size Text, specify			1.022 Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Use If Package Is Damaged