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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 K231178
Device Name ACTERA™ hip system
Applicant
Conformis Inc
600 Technology Park Dr
Fourth Floor
Billerica,  MA  01821
Applicant Contact Mary Kruitwagen
Correspondent
Conformis Inc
600 Technology Park Dr
Fourth Floor
Billerica,  MA  01821
Correspondent Contact Mary Kruitwagen
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Code
OQG  
Date Received04/26/2023
Decision Date 05/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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