Zimmer Plates And Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws And Washers

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 (zps) - Non Sterile Plate Line Extensions, Sterile/non-sterile Zps / Screws And Washers.

Pre-market Notification Details

Device IDK143066
510k NumberK143066
Device Name:Zimmer Plates And Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws And Washers
ClassificationPlate, Fixation, Bone
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactPatrick Mcullagh
CorrespondentStephen H. Mckelvey
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 Received2014-10-24
Decision Date2014-11-28
Summary:summary

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