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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 K221104
Device Name Actera™ hip system
Applicant
Conformis, Inc.
600 Technology Park Dr., 4th Floor
Billerica,  MA  01821
Applicant Contact Mary Kruitwagen
Correspondent
Conformis, Inc.
600 Technology Park Dr., 4th Floor
Billerica,  MA  01821
Correspondent Contact Mary Kruitwagen
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Code
OQG  
Date Received04/14/2022
Decision Date 08/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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