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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, metal/polymer, porous uncemented
510(k) Number K191622
Device Name Delta Multihole TT Pro Acetabular System
Applicant
Limacorporate S.p.A.
Via Nazionale 52
Villanova di San Daniele del Friuli,  IT 33038
Applicant Contact Roberto Gabetta
Correspondent
Peoples & Associates Consulting, LLC
5010 Lodge Pole Lane
Fort Wayne,  IN  46814
Correspondent Contact Stephen Peoples
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   LZO   MBL  
Date Received06/18/2019
Decision Date 11/01/2019
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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