Acetabular Cup Positioner, Threaded Shaft

Basic Information

• Brand Name: Acetabular Cup Positioner, Threaded Shaft
• Primary DI: 00819251020602
• Version / Model: 1202.00.000
• Company Name: TOTAL JOINT ORTHOPEDICS, INC.
• Labeler DUNS: 078416717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-27
• Public Version: 1
• Public Version Date: 2023-12-05
• Public Version Status: New
• Public Device Record Key: 982bb124-4c15-49ba-9102-226a207cea5f

Device Description

Acetabular Cup Positioner, Threaded Shaft

Device Characteristics

• Single Use: No
• 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: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32878	Hip prosthesis socket pusher	A hand-held manual surgical instrument with a grip designed to hold an acetabular cup or shell at the distal end. It is rod-like in shape and used to force the acetabular component of a total hip prosthesis into the proper position in the acetabular vault of the pelvis. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819251020602	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: The Klassic HD Hip System should be stored in a clean, dry location at room temperature