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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, uncemented, metal / polymer, non-porous, calcium phosphate
510(k) Number K181778
Device Name MUTARS Proximal Femur Replacement System
Applicant
implantcast GmbH
Lueneburger Schanze 26
Buxtehude,  DE 21614
Applicant Contact Juliane Hoppner
Correspondent
Musculoskeletal Clinical Regulatory Advisers, LLC
1050 K Street NW, Suite 1000
Washington,  DC  20001
Correspondent Contact Dave McGurl
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
KWY   LZO  
Date Received07/03/2018
Decision Date 03/25/2019
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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