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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shoulder prosthesis, reverse configuration
510(k) Number K212800
Device Name PRIMA Humeral System and SMR Glenosphere Ø42
Applicant
LimaCorporate S.p.A.
Via Nazionale 52
Villanova di San Daniele del friuli,  IT 33038
Applicant Contact Antonia Trevisan
Correspondent
Lima USA Inc.
2001 NE Green Oaks Blvd. Ste.100
Arlington,  TX  76006
Correspondent Contact Lacey Harbour
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWS   KWT   PAO  
Date Received09/02/2021
Decision Date 02/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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