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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 K210717
Device Name Bone Screws dia. 5,0 mm
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
KWS   KWT   MBF  
Date Received03/10/2021
Decision Date 07/12/2021
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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