Trinity Acetabular Hip System E321.022

GUDID 05055343892718

Modular head 22.2 mm Medium

CORIN LTD

Metallic femoral head prosthesis

• Primary Device ID: 05055343892718
• NIH Device Record Key: f978e50d-e733-433a-b555-b1e1a0aab10b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trinity Acetabular Hip System
• Version Model Number: E321.022
• Catalog Number: E321.022
• 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	05055343892718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170359

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Sterilization

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

[05055343892718]

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: 2017-11-16

On-Brand Devices [Trinity Acetabular Hip System]

• 05056139232336: Offset Reamer Handle (Hudson – Dual Reamer Coupling (NC))
• 05056139232329: Offset Reamer Handle (Stryker Z/H – Dual Reamer Coupling (NC))
• 05056139232312: Offset Reamer Handle (Large AO – Dual Reamer Coupling (NC))
• 05056139231988: Offset Reamer Handle (UJ Chain – Dual Coupling (NC))
• 05056139231643: Blade Retractor No°6
• 05056139231636: Bone Hook
• 05056139231629: Beckmann Retractor
• 05056139231612: Charnley Frame
• 05056139231605: Monobloc T-Handle Corkscrew
• 05056139231599: Judet Starter Rasp
• 05056139231582: Bent Curette
• 05056139231575: T-Handle Reverse Hudson
• 05056139231018: Bent Curette
• 05056139231001: Charnley Frame
• 05056139230998: Bone Hook
• 05056139230981: Beckmenn Retractor
• 05056139230974: Judet Starter Rasp
• 05055343899649: Blade Retractor No°4
• 05055343899632: Blade Retractor No°2
• 05055343899625: Blade Retractor No°3
• 05055343899618: Blade Retractor No°5
• 05055343899601: Blade Retractor No°1
• 05055343899410: Trinity Introducer Handle
• 05055343898581: Stem Insert (Size 2)
• 05055343898574: Stem Insert (Size 3, 4 & 5)
• 05055343898567: CoCr Liner Extractor
• 05055343898550: Modular Head Trial Ø22mm/-2.0/S (12/14)
• 05055343898543: Head-Insert Press
• 05055343898536: Modular Head Trial Ø22mm/+0.0/M (12/14)
• 05055343898529: Modular Head Trial Ø22mm/+2.0/L (12/14)
• 05055343897539: Liner Trial (Size 5)
• 05055343897522: Liner Trial (Size 4)
• 05055343897515: Liner Trial (Size 3)
• 05055343897508: Liner Trial (Size 2)
• 05055343897492: Insert Trial (size 5)
• 05055343897485: Insert Trial (size 4)
• 05055343897478: Insert Trial (Size 3)
• 05055343897461: Insert Trial (Size 2)
• 05055343897171: Modular head 22.2 mm Short
• 05055343897102: Straight Reamer Handle Zimmer
• 05055343896754: Straight Reamer Handle Hudson
• 05055343896747: Straight Reamer Handle AO
• 05055343896679: Offset Reamer Handle Hudson
• 05055343896662: Offset Reamer Handle Zimmer
• 05055343896655: Offset Reamer Handle AO
• 05055343896648: Alignment Guide
• 05055343896617: Offset Cup Impactor
• 05055343896143: CoCr Liner Impactor Head (Size 5)
• 05055343896136: CoCr Liner Impactor Head (Size 4)
• 05055343896129: CoCr Liner Impactor Head (Size 3)