MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM

Screw, Fixation, Bone

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Motionloc Screw For Ncb Polyaxial Locking Plating System.

Pre-market Notification Details

Device IDK101696
510k NumberK101696
Device Name:MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
ClassificationScrew, Fixation, Bone
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactStephen G Mckelvey, Ma, Rac
CorrespondentStephen G Mckelvey, Ma, Rac
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-16
Decision Date2010-09-10
Summary:summary

NIH GUDID Devices

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