Trinity™ Dual Mobility System

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

Corin USA Limited

The following data is part of a premarket notification filed by Corin Usa Limited with the FDA for Trinity™ Dual Mobility System.

Pre-market Notification Details

• Device ID: K170359
• 510k Number: K170359
• Device Name: Trinity™ Dual Mobility System
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: Corin USA Limited 5670 W Cypress Street Suite C Tampa, FL 33607
• Contact: Zak Akhoonjee
• Correspondent: Lucinda Gerber; Corin USA Limited 5670 W Cypress Street Suite C Tampa, FL 33607
• Product Code: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-02-06
• Decision Date: 2017-10-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05055343898581	K170359	000
05055343896136	K170359	000
05055343896129	K170359	000
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05055343893241	K170359	000
05055343893234	K170359	000
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05055343896143	K170359	000
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05055343897461	K170359	000
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05055343898529	K170359	000
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05055343897478	K170359	000
05055343892718	K170359	000