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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
510(k) Number K222427
Device Name PRIMA TT Glenoid
Applicant
Lima Corporate S.P.A.
Via Nazionale 52
Villanova Di San Daniele Del Friuli,  IT 33038
Applicant Contact Michela Zanotto
Correspondent
Lima U.S.A., Inc.
2001 NE Green Oaks Blvd.
Suite 100
Arlington,  TX  76006
Correspondent Contact Kenneth Newman
Regulation Number888.3670
Classification Product Code
MBF  
Subsequent Product Code
PHX  
Date Received08/11/2022
Decision Date 10/06/2022
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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