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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Arthroplasty Implantation System
510(k) Number K222405
Device Name Smart SPACE Shoulder Planner and 3D Positioners
Applicant
Lima Corporate S.P.A.
Via Nazionale 52
Villanova Di San Daniele Del Friuli,  IT 33038
Applicant Contact Francesca Marello
Correspondent
Lima U.S.A., Inc.
2001 NE Green Oaks Blvd.
Suite 100
Arlington,  TX  76006
Correspondent Contact Kenneth Newman
Regulation Number888.3660
Classification Product Code
QHE  
Subsequent Product Codes
KWS   MBF  
Date Received08/09/2022
Decision Date 12/20/2022
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
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