Corin Metafix Hip Stem

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 Corin Metafix Hip Stem.

Pre-market Notification Details

• Device ID: K153381
• 510k Number: K153381
• Device Name: Corin Metafix Hip Stem
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: Corin USA Limited 5670 W. Cypress St., Suite C Tampa, FL 33607
• Contact: Rachel King
• Correspondent: Rachel King; Corin USA Limited 5670 W. Cypress St., Suite C Tampa, FL 33607
• Product Code: LZO
• Subsequent Product Code: JDI
• Subsequent Product Code: KWL
• Subsequent Product Code: KWY
• Subsequent Product Code: MEH
• Subsequent Product Code: OQI
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-11-23
• Decision Date: 2016-01-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05055343894033	K153381	000
05055343891421	K153381	000
05055343891414	K153381	000
05055343891407	K153381	000
05055343891360	K153381	000
05055343891339	K153381	000
05055343891315	K153381	000
05055343891292	K153381	000
05055343891285	K153381	000
05055343891278	K153381	000
05055343891261	K153381	000
05055343891254	K153381	000
05055343891247	K153381	000
05055343891230	K153381	000
05055343891223	K153381	000
05055343891438	K153381	000
05055343891445	K153381	000
05055343891452	K153381	000
05055343894026	K153381	000
05055343891667	K153381	000
05055343891650	K153381	000
05055343891643	K153381	000
05055343891636	K153381	000
05055343891629	K153381	000
05055343891612	K153381	000
05055343891605	K153381	000
05055343891599	K153381	000
05055343891582	K153381	000
05055343891575	K153381	000
05055343891568	K153381	000
05055343891476	K153381	000
05055343891469	K153381	000
05055343891216	K153381	000