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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 K190656
Device Name Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
Zimmer Inc.
P.O. Box 708
warsaw,  IN  46581 -0708
Applicant Contact charles neitzel
Zimmer Inc.
P.O. Box 708
warsaw,  IN  46581 -0708
Correspondent Contact charles neitzel
Regulation Number888.3358
Classification Product Code
Subsequent Product Codes
Date Received03/14/2019
Decision Date 12/06/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls