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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, hemi-, femoral, metal/polymer, cemented or uncemented
510(k) Number K191016
Device Name COPAL exchange G Hip and Knee Spacers
Applicant
Heraeus Medical GmbH
Philipp-Reis-Str. 8/13
Werheim,  DE 61273
Applicant Contact Ljuba Jitaau
Correspondent
Alira Health
1 Grant Street
Framingham,  MA  01702
Correspondent Contact Mary McNamara-Cullinane
Regulation Number888.3390
Classification Product Code
KWY  
Subsequent Product Codes
JWH   KWL  
Date Received04/17/2019
Decision Date 11/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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