CORIN TRIFIT TS HIP

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

CORIN USA

The following data is part of a premarket notification filed by Corin Usa with the FDA for Corin Trifit Ts Hip.

Pre-market Notification Details

• Device ID: K121563
• 510k Number: K121563
• Device Name: CORIN TRIFIT TS HIP
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
• Applicant: CORIN USA 10500 UNIVERSITY CENTER DRIVE SUITE 190 Tampa, FL 33612
• Contact: Lucinda Gerber
• Correspondent: Lucinda Gerber; CORIN USA 10500 UNIVERSITY CENTER DRIVE SUITE 190 Tampa, FL 33612
• Product Code: MEH
• Subsequent Product Code: KWL
• Subsequent Product Code: KWY
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-05-29
• Decision Date: 2012-10-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05055343866788	K121563	000
05055343877173	K121563	000
05055343877180	K121563	000
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05056139231452	K121563	000