OrthoMedFlex

Basic Information

• Brand Name: OrthoMedFlex
• Primary DI: M716AC3520
• Version / Model: AC-352
• Catalog Number: AC-352
• Company Name: ORTHOMEDFLEX LLC
• Labeler DUNS: 034442726
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-08
• Public Version: 3
• Public Version Date: 2020-09-09
• Public Version Status: Update
• Public Device Record Key: ce2a61c8-c347-400b-a2e9-42f9f11da5cc

Device Description

Tryon Acetabular Cup, Size 52mm, Multi Hole - Ti6AI4V Alloy with Porous Coating

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: Yes
• 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
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	888.3358	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43167	Acetabular shell	An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M716AC3520	HIBCC

Customer Contacts

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