LOSPA Modular Knee System

Basic Information

• Brand Name: LOSPA Modular Knee System
• Primary DI: 08806373865794
• Version / Model: K2.BXP.1510
• Company Name: Corentec Co., Ltd
• Labeler DUNS: 688739895
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-31
• Public Version: 2
• Public Version Date: 2025-04-22
• Public Version Status: Update
• Public Device Record Key: 30d73bc8-d2d6-4a02-8a28-815817b95a98

Device Description

LOSPA Stem plug

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
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	888.3560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64151	Knee tibia prosthesis plug	A small, implantable threaded or non-threaded plug intended to fill the hole in the tibial baseplate of a modular knee tibia prosthesis when the knee tibial stem prosthesis is not used. It is made of metallic and/or synthetic polymer materials, and is screwed or pushed into place.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08806373865794	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160157	000