Iconacy i-Hip 01-10103-058-00

GUDID M914011010305800

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

Iconacy Orthopedic Implants LLC

Acetabular shell

• Primary Device ID: M914011010305800
• NIH Device Record Key: 82df1e3e-129f-4e5f-b3af-daae119c79a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Iconacy i-Hip
• Version Model Number: 01-10103-058-00
• Catalog Number: 01-10103-058-00
• 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: 574-269-4266
• Email: rhori@iconacy.com
• Phone: 574-269-4266
• Email: rhori@iconacy.com
• Phone: 574-269-4266
• Email: rhori@iconacy.com
• Phone: 574-269-4266
• Email: rhori@iconacy.com
• Phone: 574-269-4266
• Email: rhori@iconacy.com
• Phone: 574-269-4266
• Email: rhori@iconacy.com
• Phone: 574-269-4266
• Email: rhori@iconacy.com
• Phone: 574-269-4266
• Email: rhori@iconacy.com
• Phone: 574-269-4266
• Email: rhori@iconacy.com
• Phone: 574-269-4266
• Email: rhori@iconacy.com
• Phone: 574-269-4266
• Email: rhori@iconacy.com
• Phone: 574-269-4266
• Email: rhori@iconacy.com
• Phone: 574-269-4266
• 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	M914011010305800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131279

FDA Product Code

• LWJ: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 2015-10-30

On-Brand Devices [Iconacy i-Hip]

• M914011020301201: FEMORAL HEAD, 36MM DIAMETER, +12MM NECK
• M914011020300801: FEMORAL HEAD, 36MM DIAMETER, +8MM NECK
• M914011020300401: FEMORAL HEAD, 36MM DIAMETER, +4MM NECK
• M914011020300201: FEMORAL HEAD, 36MM DIAMETER, +0MM NECK
• M914011020300001: FEMORAL HEAD, 36MM DIAMETER, -4MM NECK
• M914011020201201: FEMORAL HEAD, 32MM DIAMETER, +12MM NECK
• M914011020200801: FEMORAL HEAD, 32MM DIAMETER, +8MM NECK
• M914011020200401: FEMORAL HEAD, 32MM DIAMETER, +4MM NECK
• M914011020200201: FEMORAL HEAD, 32MM DIAMETER, +0MM NECK
• M914011020200001: FEMORAL HEAD, 32MM DIAMETER, -4MM NECK
• M914011020101201: FEMORAL HEAD, 28MM DIAMETER, +12MM NECK
• M914011020100801: FEMORAL HEAD, 28MM DIAMETER, +8MM NECK
• M914011020100401: FEMORAL HEAD, 28MM DIAMETER, +4MM NECK
• M914011020100201: FEMORAL HEAD, 28MM DIAMETER, +0MM NECK
• M914011020100001: FEMORAL HEAD, 28MM DIAMETER, -4MM NECK
• M914011010406400: ACETABULAR CUP, 2-HOLE, 64MM O.D.
• M914011010406200: ACETABULAR CUP, 2-HOLE, 62MM O.D.
• M914011010406000: ACETABULAR CUP, 2-HOLE, 60MM O.D.
• M914011010405800: ACETABULAR CUP, 2-HOLE, 58MM O.D.
• M914011010405600: ACETABULAR CUP, 2-HOLE, 56MM O.D.
• M914011010405400: ACETABULAR CUP, 2-HOLE, 54MM O.D.
• M914011010405200: ACETABULAR CUP, 2-HOLE, 52MM O.D.
• M914011010405000: ACETABULAR CUP, 2-HOLE, 50MM O.D.
• M914011010404800: ACETABULAR CUP, 2-HOLE, 48MM O.D.
• M914011010404600: ACETABULAR CUP, 2-HOLE, 46MM O.D.
• M914011010306400: RS ACETABULAR CUP, FINNED, 2-HOLE, 64MM O.D.
• M914011010306200: RS ACETABULAR CUP, FINNED, 2-HOLE, 62MM O.D.
• M914011010306000: RS ACETABULAR CUP, FINNED, 2-HOLE, 60MM O.D.
• M914011010305800: RS ACETABULAR CUP, FINNED, 2-HOLE, 58MM O.D.
• M914011010305600: RS ACETABULAR CUP, FINNED, 2-HOLE, 56MM O.D.
• M914011010305400: RS ACETABULAR CUP, FINNED, 2-HOLE, 54MM O.D.
• M914011010305200: RS ACETABULAR CUP, FINNED, 2-HOLE, 52MM O.D.
• M914011010305000: RS ACETABULAR CUP, FINNED, 2-HOLE, 50MM O.D.
• M914011010304800: RS ACETABULAR CUP, FINNED, 2-HOLE, 48MM O.D.
• M914011010304600: RS ACETABULAR CUP, FINNED, 2-HOLE, 46MM O.D.
• M914011010206400: RS ACETABULAR CUP, SPIKED, 64MM O.D.
• M914011010206200: RS ACETABULAR CUP, SPIKED, 62MM O.D.
• M914011010206000: RS ACETABULAR CUP, SPIKED, 60MM O.D.
• M914011010205800: RS ACETABULAR CUP, SPIKED, 58MM O.D.
• M914011010205600: RS ACETABULAR CUP, SPIKED, 56MM O.D.
• M914011010205400: RS ACETABULAR CUP, SPIKED, 54MM O.D.
• M914011010205200: RS ACETABULAR CUP, SPIKED, 52MM O.D.
• M914011010205000: RS ACETABULAR CUP, SPIKED, 50MM O.D.
• M914011010204800: RS ACETABULAR CUP, SPIKED, 48MM O.D.
• M914011010204600: RS ACETABULAR CUP, SPIKED, 46MM O.D.
• M914011010106400: RS ACETABULAR CUP, 2-HOLE, 64MM O.D.
• M914011010106200: RS ACETABULAR CUP, 2-HOLE, 62MM O.D.
• M914011010106000: RS ACETABULAR CUP, 2-HOLE, 60MM O.D.
• M914011010105600: RS ACETABULAR CUP, 2-HOLE, 56MM O.D.
• M914011010105400: RS ACETABULAR CUP, 2-HOLE, 54MM O.D.