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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 K220492
Device Name COPAL exchange G hip spacer
Applicant
Heraeus Medical GmbH
Philipp-Reis-Str. 8/13
Wehrheim,  DE 61273
Applicant Contact Heike Gustke
Correspondent
Heraeus Medical GmbH
Philipp-Reis-Str. 8/13
Wehrheim,  DE 61273
Correspondent Contact Heike Gustke
Regulation Number888.3390
Classification Product Code
KWY  
Subsequent Product Code
KWL  
Date Received02/22/2022
Decision Date 03/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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