TI REPICCI II® KNEE SYSTEM

Basic Information

• Brand Name: TI REPICCI II® KNEE SYSTEM
• Primary DI: 00880304653115
• Version / Model: CP112961
• Catalog Number: CP112961
• Company Name: Biomet Orthopedics, LLC
• Labeler DUNS: 129278169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-08
• Public Version: 1
• Public Version Date: 2018-07-09
• Public Version Status: New
• Public Device Record Key: a3e41c38-ed8d-47d4-8151-0475337e71b1

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
HRY	PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER	Orthopedic	888.3530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61271	Femoral stem centralizer	A small sterile implantable device intended to be used during the implantation of a cemented femoral stem prosthesis to centralize and stabilize the prosthesis tip within the femoral medullary canal; it is inserted into the medullary canal prior to cement insertion. It is made of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] and may have a winged structure.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00880304653115	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K063515	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			51 MM