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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 K121636
Device Name ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT
Applicant
TGM MEDICAL, INC.
5145 Golden Foothill Parkway
SUITE 175
El Dorado Hills,  CA  95762
Applicant Contact PRAKASH PAI
Correspondent
TGM MEDICAL, INC.
5145 Golden Foothill Parkway
SUITE 175
El Dorado Hills,  CA  95762
Correspondent Contact PRAKASH PAI
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received06/04/2012
Decision Date 10/24/2012
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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