OrthoMedFlex

Basic Information

• Brand Name: OrthoMedFlex
• Primary DI: M7161111620020
• Version / Model: 111162002
• Catalog Number: 111-162-002
• Company Name: ORTHOMEDFLEX LLC
• Labeler DUNS: 034442726
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-17
• Public Version: 1
• Public Version Date: 2020-04-27
• Public Version Status: New
• Public Device Record Key: f561cd58-f43d-4336-8545-19f13a49d629

Device Description

Distal Tip Centralizer

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate	Orthopedic	888.3353	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	M7161111620020	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121297	000