Corin Taper-Fit Total Hip System E088.226

GUDID 05055196929722

MODULAR HEAD

CORIN LTD

Metallic femoral head prosthesis

• Primary Device ID: 05055196929722
• NIH Device Record Key: 48760a4a-2acf-4f68-8ca7-8d92184a3826
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Corin Taper-Fit Total Hip System
• Version Model Number: E088.226
• Catalog Number: E088.226
• Company DUNS: 295437313
• Company Name: CORIN LTD
• 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: +441285659866
• Email: rachel.king@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055196929722 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992234

FDA Product Code

• JDG: Prosthesis, hip, femoral component, cemented, metal

Sterilization

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

[05055196929722]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-08-17

On-Brand Devices [Corin Taper-Fit Total Hip System]

• 05055343850695: MODULAR HEAD TRIAL LONG 32MM
• 05055343850688: MODULAR HEAD TRIAL LONG 28MM
• 05055343850657: MODULAR HEAD TRIAL STD 32MM
• 05055343850640: MODULAR HEAD TRIAL STD 28MM
• 05055343850619: MODULAR HEAD TRIAL SHORT 32MM
• 05055343850602: MODULAR HEAD TRIAL SHORT 28MM
• 05055343826928: SLAP HAMMER
• 05055343826850: FIXED T HANDLE TAPERED REAMER
• 05055343826843: BOX OSTEOTOME
• 05055196998902: TAPERFIT STEM CENTRALISER (Pack 5)
• 05055196998896: TAPERFIT STEM CENTRALISER
• 05055196960787: TAPERFIT STEM
• 05055196960770: TAPERFIT STEM
• 05055196960763: TAPERFIT STEM
• 05055196960756: TAPERFIT STEM
• 05055196960749: TAPERFIT STEM
• 05055196960732: TAPERFIT STEM
• 05055196960725: TAPERFIT STEM
• 05055196960718: TAPERFIT STEM
• 05055196960701: TAPERFIT STEM
• 05055196957435: CDH EASP
• 05055196957428: 45MM OFFSET RASP SIZE 4
• 05055196957411: 45MM OFFSET RASP SIZE 3
• 05055196957404: 45MM OFFSET RASP SIZE 2
• 05055196957398: 45MM OFFSET RASP SIZE 1
• 05055196957374: 38MM OFFSET RASP SIZE 4
• 05055196957367: 38MM OFFSET RASP SIZE 3
• 05055196957350: 38MM OFFSET RASP SIZE 2
• 05055196957343: 38MM OFFSET RASP SIZE 1
• 05055196957329: 70MM LOCATING PIN
• 05055196957305: BUTTON EXTENSION TOMMY BAR
• 05055196957299: RASP HANDLE BUTTON EXTENSION
• 05055196957282: STEM INTRODUCER
• 05055196957275: TAPERFIT RASP HANDLE
• 05055196957091: CDH TRIAL NECK (EUROCONE)
• 05055196957084: 38MM & 45MM OFFSET TRIAL NECK (EUROCONE)
• 05055196957077: CDH TRIAL STEM
• 05055196957060: 45MM OFFSET TRIAL STEM SIZE 4
• 05055196957053: 45MM OFFSET TRIAL STEM SIZE 3
• 05055196957046: 45MM OFFSET TRIAL STEM SIZE 2
• 05055196957039: 45MM OFFSET TRIAL STEM SIZE 1
• 05055196957022: 38MM OFFSET TRIAL STEM SIZE 1
• 05055196957015: 38MM OFFSET TRIAL STEM SIZE 1
• 05055196957008: 38MM OFFSET TRIAL STEM SIZE 1
• 05055196956995: 38MM OFFSET TRIAL STEM SIZE 1
• 05055196940604: ALLEN KEY
• 05055196929739: MODULAR HEAD
• 05055196929722: MODULAR HEAD
• 05055196929715: MODULAR HEAD
• 05055196929692: MODULAR HEAD