ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS

Plate, Fixation, Bone

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Plates And Screws System(zps)- Non-sterile Plates And Screws.

Pre-market Notification Details

Device IDK140508
510k NumberK140508
Device Name:ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS
ClassificationPlate, Fixation, Bone
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactStephen H Mckelvey, Ma, Rac
CorrespondentStephen H Mckelvey, Ma, Rac
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeHRS  
Subsequent Product CodeHTN
Subsequent Product CodeHWC
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-28
Decision Date2014-08-14
Summary:summary

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