ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM

Screw, Fixation, Bone

ZIMMER, INC.

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

Pre-market Notification Details

Device IDK130810
510k NumberK130810
Device Name:ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
ClassificationScrew, Fixation, Bone
Applicant ZIMMER, INC. 9001 WESLEYAN ROAD, STE 200 Indianapolis,  IN  46268
ContactScott M Durlacher
CorrespondentScott M Durlacher
ZIMMER, INC. 9001 WESLEYAN ROAD, STE 200 Indianapolis,  IN  46268
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-25
Decision Date2013-09-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024090293 K130810 000
00889024091221 K130810 000
00889024091245 K130810 000
00889024091290 K130810 000
00889024091313 K130810 000
00889024091351 K130810 000
00889024091375 K130810 000
00889024091443 K130810 000
00889024091467 K130810 000
00889024091504 K130810 000
00889024091528 K130810 000
00889024091580 K130810 000
00889024091603 K130810 000
00889024091658 K130810 000
00889024091122 K130810 000
00889024091108 K130810 000
00889024091030 K130810 000
00889024090385 K130810 000
00889024090408 K130810 000
00889024090484 K130810 000
00889024090507 K130810 000
00889024090583 K130810 000
00889024090606 K130810 000
00889024090705 K130810 000
00889024090729 K130810 000
00889024090804 K130810 000
00889024090828 K130810 000
00889024090897 K130810 000
00889024090910 K130810 000
00889024091016 K130810 000
00889024091665 K130810 000
00889024091696 K130810 000
00889024058361 K130810 000
00889024058460 K130810 000
00889024058484 K130810 000
00889024058552 K130810 000
00889024058576 K130810 000
00889024058675 K130810 000
00889024058699 K130810 000
00889024058743 K130810 000
00889024058767 K130810 000
00889024058804 K130810 000
00889024058828 K130810 000
00889024058903 K130810 000
00889024058958 K130810 000
00889024058347 K130810 000
00889024058279 K130810 000
00889024058255 K130810 000
00889024091702 K130810 000
00889024091795 K130810 000
00889024091801 K130810 000
00889024091832 K130810 000
00889024091849 K130810 000
00889024091900 K130810 000
00889024091924 K130810 000
00889024057777 K130810 000
00889024057869 K130810 000
00889024057951 K130810 000
00889024058040 K130810 000
00889024058156 K130810 000
00889024058170 K130810 000
00889024059023 K130810 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.