Trinity Acetabular Hip System with HXLPE Liners 321.04.928

GUDID 05055196971660

Trinity Liner (HXLPE) Ø28mm Neutral 4mm EPW Taper Size 4

CORIN LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 05055196971660
• NIH Device Record Key: 6eec0c06-fe71-4918-b6f6-5c3e7c5f0a27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trinity Acetabular Hip System with HXLPE Liners
• Version Model Number: 321.04.928
• Catalog Number: 321.04.928
• 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: lucinda.gerber@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055196971660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110087

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

[05055196971660]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-17

On-Brand Devices [Trinity Acetabular Hip System with HXLPE Liners]

• 05055343890448: Screw Hole Depth Gauge
• 05055343886908: FLEXIBLE DRILL DRIVER
• 05055343870839: Suction Cup Bellows Type - TRINITY SPARE
• 05055343868683: MODULAR SCREWDRIVER
• 05055343867655: PE LINER EXTRACTOR
• 05055343866054: LOCKABLE ANTEVERSION GUIDE
• 05055343865248: MIS LINER INTRODUCER
• 05055343865231: PUSHER/INTRODUCER
• 05055343865224: STRAIGHT INTRODUCER/IMPACTOR HANDLE
• 05055343865217: MIS PUSHER/INTRODUCER
• 05055343865101: MODULAR UJ SCREWDRIVER
• 05055343865088: MODULAR SCREWDRIVER BALL END
• 05055343827970: ACETABULAR REAMER - Ø68mm
• 05055343827963: ACETABULAR REAMER - Ø67mm
• 05055343827956: ACETABULAR REAMER - Ø66mm
• 05055343827949: ACETABULAR REAMER - Ø65mm
• 05055343827932: ACETABULAR REAMER - Ø64mm
• 05055343827925: ACETABULAR REAMER - Ø63mm
• 05055343827918: ACETABULAR REAMER - Ø62mm
• 05055343827901: ACETABULAR REAMER - Ø61mm
• 05055343827895: ACETABULAR REAMER - Ø60mm
• 05055343827888: ACETABULAR REAMER - Ø59mm
• 05055343827871: ACETABULAR REAMER - Ø58mm
• 05055343827864: ACETABULAR REAMER - Ø57mm
• 05055343827857: ACETABULAR REAMER - Ø56mm
• 05055343827840: ACETABULAR REAMER - Ø55mm
• 05055343827833: ACETABULAR REAMER - Ø54mm
• 05055343827826: ACETABULAR REAMER - Ø53mm
• 05055343827819: ACETABULAR REAMER - Ø52mm
• 05055343827802: ACETABULAR REAMER - Ø51mm
• 05055343827796: ACETABULAR REAMER - Ø50mm
• 05055343827789: ACETABULAR REAMER - Ø49mm
• 05055343827772: ACETABULAR REAMER - Ø48mm
• 05055343827765: ACETABULAR REAMER - Ø47mm
• 05055343827758: ACETABULAR REAMER - Ø46mm
• 05055343827741: ACETABULAR REAMER - Ø45mm
• 05055343827734: ACETABULAR REAMER - Ø44mm
• 05055343827727: ACETABULAR REAMER - Ø43mm
• 05055343827710: ACETABULAR REAMER - Ø42mm
• 05055343827703: ACETABULAR REAMER - Ø41mm
• 05055343827697: ACETABULAR REAMER - Ø40mm
• 05055343827680: ACETABULAR REAMER - Ø39mm
• 05055343827673: ACETABULAR REAMER - Ø38mm
• 05055343827659: STRAIGHT REAMER DRIVE HANDLE - AO DRIVE
• 05055343827079: DRIVE ADAPTOR - AO MALE TO HUDSON/JACOBS MALE
• 05055196972681: LINER IMPACTOR. SIZE 40mm
• 05055196972674: LINER IMPACTOR. SIZE 36mm
• 05055196972650: LINER IMPACTOR. SIZE 28mm
• 05055196971868: MIS INTRODUCER/IMPACTOR HANDLE
• 05055196971851: Trinity Liner (HXLPE) Ø40mm Neutral 4mm EPW Taper Size 5