Trinity Acetabular Hip System with ECiMa Liners 322.01.628

GUDID 05055343868263

Trinity Liner (ECIMA) Ø28mm Neutral Offset Taper Size 1

CORIN LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 05055343868263
• NIH Device Record Key: 3ac5b98f-b12c-4a57-bf74-fa1ebae0e121
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trinity Acetabular Hip System with ECiMa Liners
• Version Model Number: 322.01.628
• Catalog Number: 322.01.628
• 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	05055343868263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111481

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

[05055343868263]

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 ECiMa Liners]

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• 05055343870075: Trinity Liner (ECIMA) Ø32mm Neutral Offset Taper Size 2
• 05055343870068: Trinity Liner (ECIMA) Ø28mm Neutral 4mm EPW Taper Size 5
• 05055343870051: Trinity Liner (ECIMA) Ø28mm Neutral 4mm EPW Taper Size 4
• 05055343870044: Trinity Liner (ECIMA) Ø28mm Neutral 4mm EPW Taper Size 3
• 05055343870037: Trinity Liner (ECIMA) Ø28mm Neutral 4mm EPW Taper Size 2
• 05055343870020: Trinity Liner (ECIMA) Ø28mm +4mm Oblique Taper Size 4
• 05055343870013: Trinity Liner (ECIMA) Ø28mm +4mm Oblique Taper Size 3
• 05055343870006: Trinity Liner (ECIMA) Ø28mm +4mm Oblique Taper Size 2
• 05055343869994: Trinity Liner (ECIMA) Ø28mm +4mm Offset Taper Size 5
• 05055343869987: Trinity Liner (ECIMA) Ø28mm +4mm Offset Taper Size 4
• 05055343869970: Trinity Liner (ECIMA) Ø28mm +4mm Offset Taper Size 3
• 05055343869963: Trinity Liner (ECIMA) Ø28mm +4mm Offset Taper Size 2
• 05055343869956: Trinity Liner (ECIMA) Ø28mm Neutral Offset Taper Size 5
• 05055343869949: Trinity Liner (ECIMA) Ø28mm Neutral Offset Taper Size 4
• 05055343869932: Trinity Liner (ECIMA) Ø28mm Neutral Offset Taper Size 3
• 05055343869925: Trinity Liner (ECIMA) Ø28mm Neutral Offset Taper Size 2
• 05055343869918: Trinity Liner (ECIMA) Ø40mm Neutral 4mm EPW Taper Size 5
• 05055343869901: Trinity Liner (ECIMA) Ø36mm Neutral 4mm EPW Taper Size 5
• 05055343869895: Trinity Liner (ECIMA) Ø32mm Neutral 4mm EPW Taper Size 5
• 05055343869888: Trinity Liner (ECIMA) Ø40mm Neutral 4mm EPW Taper Size 4
• 05055343869871: Trinity Liner (ECIMA) Ø36mm Neutral 4mm EPW Taper Size 4
• 05055343869864: Trinity Liner (ECIMA) Ø32mm Neutral 4mm EPW Taper Size 4
• 05055343869857: Trinity Liner (ECIMA) Ø36mm Neutral 4mm EPW Taper Size 3
• 05055343869840: Trinity Liner (ECIMA) Ø32mm Neutral 4mm EPW Taper Size 3
• 05055343869833: Trinity Liner (ECIMA) Ø32mm Neutral 4mm EPW Taper Size 2
• 05055343869826: Trinity Liner (ECIMA) Ø28mm Neutral 4mm EPW Taper Size 1
• 05055343869819: Trinity Liner (ECIMA) Ø40mm +4mm Oblique Taper Size 5
• 05055343869802: Trinity Liner (ECIMA) Ø36mm +4mm Oblique Taper Size 5
• 05055343869796: Trinity Liner (ECIMA) Ø32mm +4mm Oblique Taper Size 5
• 05055343869789: Trinity Liner (ECIMA) Ø40mm +4mm Oblique Taper Size 4
• 05055343869772: Trinity Liner (ECIMA) Ø36mm +4mm Oblique Taper Size 4
• 05055343869765: Trinity Liner (ECIMA) Ø32mm +4mm Oblique Taper Size 4
• 05055343869758: Trinity Liner (ECIMA) Ø36mm +4mm Oblique Taper Size 3
• 05055343869741: Trinity Liner (ECIMA) Ø32mm +4mm Oblique Taper Size 3
• 05055343869734: Trinity Liner (ECIMA) Ø32mm +4mm Oblique Taper Size 2
• 05055343869727: Trinity Liner (ECIMA) Ø28mm +4mm Oblique Taper Size 1
• 05055343869710: Trinity Liner (ECIMA) Ø40mm +4mm Offset Taper Size 5
• 05055343869703: Trinity Liner (ECIMA) Ø36mm +4mm Offset Taper Size 5
• 05055343869697: Trinity Liner (ECIMA) Ø32mm +4mm Offset Taper Size 5
• 05055343869680: Trinity Liner (ECIMA) Ø40mm +4mm Offset Taper Size 4
• 05055343869673: Trinity Liner (ECIMA) Ø36mm +4mm Offset Taper Size 4
• 05055343869666: Trinity Liner (ECIMA) Ø32mm +4mm Offset Taper Size 4
• 05055343869659: Trinity Liner (ECIMA) Ø36mm +4mm Offset Taper Size 3
• 05055343869642: Trinity Liner (ECIMA) Ø32mm +4mm Offset Taper Size 3
• 05055343869635: Trinity Liner (ECIMA) Ø32mm +4mm Offset Taper Size 2
• 05055343869628: Trinity Liner (ECIMA) Ø28mm +4mm Offset Taper Size 1
• 05055343869611: Trinity Liner (ECIMA) Ø40mm Neutral Offset Taper Size 5
• 05055343869604: Trinity Liner (ECIMA) Ø36mm Neutral Offset Taper Size 5
• 05055343869598: Trinity Liner (ECIMA) Ø32mm Neutral Offset Taper Size 5