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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
510(k) Number K193545
Device Name Corin Optimized Positioning System (OPS) Femoral
Applicant
Corin USA
12750 Citrus Park Lane
Suite 120
Tampa,  FL  33625
Applicant Contact Lucinda Gerber
Correspondent
Corin (Australia)
17 Bridge Street
Sydney,  AU 2073
Correspondent Contact Crissy Tomarelli
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
LWJ   MEH   PBF  
Date Received12/20/2019
Decision Date 08/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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