Iconacy i_hip 01-10101-058-00

GUDID M914011010105800

RS ACETABULAR CUP, 2-HOLE, 58MM O.D.

Iconacy Orthopedic Implants LLC

Acetabular shell

• Primary Device ID: M914011010105800
• NIH Device Record Key: 9b569fe8-7000-44c2-bf6e-cac5b7ad25e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Iconacy i_hip
• Version Model Number: 01-10101-058-00
• Catalog Number: 01-10101-058-00
• Company DUNS: 032218374
• Company Name: Iconacy Orthopedic Implants LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 574-2694266
• Email: rhori@iconacy.com
• Phone: 574-2694266
• Email: rhori@iconacy.com
• Phone: 574-2694266
• Email: rhori@iconacy.com
• Phone: 574-2694266
• Email: rhori@iconacy.com
• Phone: 574-2694266
• Email: rhori@iconacy.com
• Phone: 574-2694266
• Email: rhori@iconacy.com
• Phone: 574-2694266
• Email: rhori@iconacy.com
• Phone: 574-2694266
• Email: rhori@iconacy.com
• Phone: 574-2694266
• Email: rhori@iconacy.com
• Phone: 574-2694266
• Email: rhori@iconacy.com
• Phone: 574-2694266
• Email: rhori@iconacy.com
• Phone: 574-2694266
• Email: rhori@iconacy.com
• Phone: 574-2694266
• Email: rhori@iconacy.com

Device Dimensions

• Outer Diameter: 58 Millimeter
• Outer Diameter: 58 Millimeter
• Outer Diameter: 58 Millimeter
• Outer Diameter: 58 Millimeter
• Outer Diameter: 58 Millimeter
• Outer Diameter: 58 Millimeter
• Outer Diameter: 58 Millimeter
• Outer Diameter: 58 Millimeter
• Outer Diameter: 58 Millimeter
• Outer Diameter: 58 Millimeter
• Outer Diameter: 58 Millimeter
• Outer Diameter: 58 Millimeter
• Outer Diameter: 58 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M914011010105800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131279

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2015-10-16

Devices Manufactured by Iconacy Orthopedic Implants LLC

• M914011010104600 - Iconacy i-Hip: 2020-09-09 RS ACETABULAR CUP, 2-HOLE, 46MM O.D.
• M914011010104800 - Iconacy i-Hip: 2020-09-09 RS ACETABULAR CUP, 2-HOLE, 48MM O.D.
• M914011010105000 - Iconacy i-Hip: 2020-09-09 RS ACETABULAR CUP, 2-HOLE, 50MM O.D.
• M914011010105200 - Iconacy i-Hip: 2020-09-09 RS ACETABULAR CUP, 2-HOLE, 52M O.D.
• M914011010105400 - Iconacy i-Hip: 2020-09-09 RS ACETABULAR CUP, 2-HOLE, 54MM O.D.
• M914011010105600 - Iconacy i-Hip: 2020-09-09 RS ACETABULAR CUP, 2-HOLE, 56MM O.D.
• M914011010105800 - Iconacy i_hip: 2020-09-09RS ACETABULAR CUP, 2-HOLE, 58MM O.D.
• M914011010105800 - Iconacy i_hip: 2020-09-09 RS ACETABULAR CUP, 2-HOLE, 58MM O.D.
• M914011010106000 - Iconacy i-Hip: 2020-09-09 RS ACETABULAR CUP, 2-HOLE, 60MM O.D.