Iconacy i-Hip

Basic Information

• Brand Name: Iconacy i-Hip
• Primary DI: M914013030306400
• Version / Model: 01-30303-064-00
• Catalog Number: 01-30303-064-00
• Company Name: Iconacy Orthopedic Implants LLC
• Labeler DUNS: 032218374
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: acd9c2e0-924f-41a6-89b6-e371d878300c

Device Description

RS ACETABULAR CUP LOCKING RING, 64MM

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

GMDN Terms

Code	Name	Definition	Implantable	Status
61770	Acetabular liner locking ring	A sterile implantable metallic ring-shaped device intended to retain an acetabular liner component within an acetabular shell component of a total hip prosthesis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M914013030306400	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K131279	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	64	Millimeter