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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, uncemented, metal / polymer, non-porous, calcium phosphate
510(k) Number K912263
Device Name HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact CHRISTOPHER PETERSON
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact CHRISTOPHER PETERSON
Regulation Number888.3353
Classification Product Code
MEH  
Date Received05/22/1991
Decision Date 08/29/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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