MyKnee PPS-Pin Positioners

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Myknee Pps-pin Positioners.

Pre-market Notification Details

Device IDK170106
510k NumberK170106
Device Name:MyKnee PPS-Pin Positioners
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Medacta International SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentElizabeth Rose
Mapi USA, Inc 2343 Alexandria Drive Suite 100 Lexington,  KY  40504
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-12
Decision Date2017-10-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630030897603 K170106 000
07630040714488 K170106 000
07630040714501 K170106 000
07630040714525 K170106 000
07630040714549 K170106 000
07630040714563 K170106 000
07630040714587 K170106 000
07630040714600 K170106 000
07630040714624 K170106 000
07630040714648 K170106 000
07630040714662 K170106 000
07630040714686 K170106 000
07630040714709 K170106 000
07630040714723 K170106 000
07630030898372 K170106 000
07630030898365 K170106 000
07630030898358 K170106 000
07630030897610 K170106 000
07630030897641 K170106 000
07630030897658 K170106 000
07630030897689 K170106 000
07630030897696 K170106 000
07630030897726 K170106 000
07630030897733 K170106 000
07630030897764 K170106 000
07630030897771 K170106 000
07630030897795 K170106 000
07630030898327 K170106 000
07630030898334 K170106 000
07630030898341 K170106 000
07630040714747 K170106 000
07630040714761 K170106 000
07630040714785 K170106 000
07630040715133 K170106 000
07630040715140 K170106 000
07630040715171 K170106 000
07630040715188 K170106 000
07630040715201 K170106 000
07630040715232 K170106 000
07630040715249 K170106 000
07630040715270 K170106 000
07630040715287 K170106 000
07630040715317 K170106 000
07630040715324 K170106 000
07630040715355 K170106 000
07630040715362 K170106 000
07630040715102 K170106 000
07630040715096 K170106 000
07630040715065 K170106 000
07630040714808 K170106 000
07630040714822 K170106 000
07630040714846 K170106 000
07630040714860 K170106 000
07630040714884 K170106 000
07630040714907 K170106 000
07630040714921 K170106 000
07630040714945 K170106 000
07630040714976 K170106 000
07630040714983 K170106 000
07630040715010 K170106 000
07630040715027 K170106 000
07630040715058 K170106 000
07630040715393 K170106 000
07630030897573 K170106 000
07630040732567 K170106 000
07630040733175 K170106 000
07630040733205 K170106 000
07630040733212 K170106 000
07630040733243 K170106 000
07630040733250 K170106 000
07630040733281 K170106 000
07630040733298 K170106 000
07630040733328 K170106 000
07630040733335 K170106 000
07630040733366 K170106 000
07630040733373 K170106 000
07630040733403 K170106 000
07630040733410 K170106 000
07630040733151 K170106 000
07630040733144 K170106 000
07630040733113 K170106 000
07630040732826 K170106 000
07630040715430 K170106 000
07630040715447 K170106 000
07630040715461 K170106 000
07630040732949 K170106 000
07630040732956 K170106 000
07630040732987 K170106 000
07630040732994 K170106 000
07630040733021 K170106 000
07630040733038 K170106 000
07630040733069 K170106 000
07630040733076 K170106 000
07630040733106 K170106 000
07630040733434 K170106 000
07630030896873 K170106 000
07630030896897 K170106 000
07630030897306 K170106 000
07630030897313 K170106 000
07630030897344 K170106 000
07630030897351 K170106 000
07630030897382 K170106 000
07630030897399 K170106 000
07630030897429 K170106 000
07630030897436 K170106 000
07630030897467 K170106 000
07630030897474 K170106 000
07630030897504 K170106 000
07630030897511 K170106 000
07630030897535 K170106 000
07630030897214 K170106 000
07630030897191 K170106 000
07630030897177 K170106 000
07630030896910 K170106 000
07630030896934 K170106 000
07630030896958 K170106 000
07630030896972 K170106 000
07630030896996 K170106 000
07630030897016 K170106 000
07630030897030 K170106 000
07630030897054 K170106 000
07630030897078 K170106 000
07630030897092 K170106 000
07630030897115 K170106 000
07630030897139 K170106 000
07630030897153 K170106 000
07630030897566 K170106 000
07630030897405 K170106 000
07630040714594 K170106 000
07630040714617 K170106 000
07630040714631 K170106 000
07630040714655 K170106 000
07630040714679 K170106 000
07630040714693 K170106 000
07630040714716 K170106 000
07630040714730 K170106 000
07630040714754 K170106 000
07630040714778 K170106 000
07630040714792 K170106 000
07630040714815 K170106 000
07630040714839 K170106 000
07630040714570 K170106 000
07630040714556 K170106 000
07630040714532 K170106 000
07630030897443 K170106 000
07630030897481 K170106 000
07630030897528 K170106 000
07630030897542 K170106 000
07630030897580 K170106 000
07630030897627 K170106 000
07630030897665 K170106 000
07630030897702 K170106 000
07630030897740 K170106 000
07630030897788 K170106 000
07630040714471 K170106 000
07630040714495 K170106 000
07630040714518 K170106 000
07630040714853 K170106 000
07630040714877 K170106 000
07630040714891 K170106 000
07630040732925 K170106 000
07630040732963 K170106 000
07630040733007 K170106 000
07630040733045 K170106 000
07630040733083 K170106 000
07630040733120 K170106 000
07630040733168 K170106 000
07630040733182 K170106 000
07630040733229 K170106 000
07630040733267 K170106 000
07630040733304 K170106 000
07630040733342 K170106 000
07630040733380 K170106 000
07630040715454 K170106 000
07630040715416 K170106 000
07630040715379 K170106 000
07630040714914 K170106 000
07630040714938 K170106 000
07630040714952 K170106 000
07630040714990 K170106 000
07630040715034 K170106 000
07630040715072 K170106 000
07630040715119 K170106 000
07630040715157 K170106 000
07630040715195 K170106 000
07630040715218 K170106 000
07630040715256 K170106 000
07630040715294 K170106 000
07630040715331 K170106 000
07630040733427 K170106 000
07630030897368 K170106 000
07630040715409 K170106 000
07630040715126 K170106 000
07630040715164 K170106 000
07630040715225 K170106 000
07630040715263 K170106 000
07630040715300 K170106 000
07630040715348 K170106 000
07630040715386 K170106 000
07630040715423 K170106 000
07630040732932 K170106 000
07630040732970 K170106 000
07630040733014 K170106 000
07630040733052 K170106 000
07630040733090 K170106 000
07630040715089 K170106 000
07630040715041 K170106 000
07630040715003 K170106 000
07630030897290 K170106 000
07630030897337 K170106 000
07630030897375 K170106 000
07630030897412 K170106 000
07630030897450 K170106 000
07630030897498 K170106 000
07630030897559 K170106 000
07630030897597 K170106 000
07630030897634 K170106 000
07630030897672 K170106 000
07630030897719 K170106 000
07630030897757 K170106 000
07630040714969 K170106 000
07630040733137 K170106 000
07630040733199 K170106 000
07630040733236 K170106 000
07630030897108 K170106 000
07630030897122 K170106 000
07630030897146 K170106 000
07630030897160 K170106 000
07630030897184 K170106 000
07630030897207 K170106 000
07630030897221 K170106 000
07630030897238 K170106 000
07630030897245 K170106 000
07630030897252 K170106 000
07630030897269 K170106 000
07630030897276 K170106 000
07630030897283 K170106 000
07630030897085 K170106 000
07630030897061 K170106 000
07630030897047 K170106 000
07630040733274 K170106 000
07630040733311 K170106 000
07630040733359 K170106 000
07630040733397 K170106 000
07630030896866 K170106 000
07630030896880 K170106 000
07630030896903 K170106 000
07630030896927 K170106 000
07630030896941 K170106 000
07630030896965 K170106 000
07630030896989 K170106 000
07630030897009 K170106 000
07630030897023 K170106 000
07630030897320 K170106 000
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.