FDA.reportPublic FDA data

ZIMMER CAS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96178403003714383ZIMMER CAS1N2027-01-0175 QUEEN ST., SUITE 3300 MONTREAL, QUEBEC CA H3C 2N6

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
809572031937800K261510Signature™ ONE SystemQHE2026-06-04
809571011070266K260582ROSA® Shoulder SystemOLO2026-05-21
809571478769827K260104Signature™ ONE SystemQHE2026-02-04
809571198559609K251314Rosa® Knee SystemOLO2025-11-13
809571140955921K242864ROSA® Knee SystemOLO2024-10-18
809571008369330K233199ROSA® Shoulder SystemOLO2024-02-21
809572056984610K232533ROSA Partial Knee SystemOLO2023-11-16
809572021681268K232425Signature™ ONE SystemQHE2023-12-12
809571389068347K231162ROSA Hip SystemLLZ2023-05-23
809571530828870K230567OptiVu™ ROSA® MxRSBF2023-06-13
809571083675185K230243ROSA® Knee SystemOLO2023-03-29
809571047587151K230180Rosa Knee SystemOLO2023-02-22
809571812230988K221928ROSA® Knee SystemOLO2022-10-04
809571964606136K220733OptiVu ROSA MxRSBF2022-07-29
809571944499456K213708ROSA® Knee SystemOLO2022-04-22
809571117534488K213033iASSIST Knee SystemOLO2022-01-14
809571654736728K212560Signature™ ONE SystemQHE2021-10-12
809571737084714K210998ROSA Hip SystemLLZ2021-08-17
809571995237831K210653ONE Planner HipLLZ2021-07-07
809571009567224K210121ROSA Partial Knee SystemOLO2021-04-19
809571473688197K200615Signature ONE SystemQHE2020-06-05
809571259707034K192080iASSIST Knee SystemOLO2019-11-05
809572036737676K192074Signature ONE SystemQHE2019-08-30
809571241891476K190595Signature ONE SystemKWT2019-06-05
809571338017277K183544Efficient Care 3D PlanningLLZ2019-08-23
809571800671308K182964ROSA Knee SystemOLO2019-01-24
809571521222416K171269X-PSI Knee SystemJWH2017-12-28
809571726958401K150730Zimmer PSI Shoulder SystemKWT2015-06-16
809571316901800K141601IASSIST KNEE SYSTEMOLO2014-09-11
809571305029499K132104ELIBRA SOFT-TISSUE FORCE SENSORONN2014-03-21
809571006749220K131409CAS PSI KNEE SYSTEMJWH2013-09-13
809571814918435K131129CAS PSI SHOULDERKWS2013-08-20
809571271244257K122326SMARTTOOLS KNEE SYSTEMOLO2012-11-30
809571788139925K110054NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCEOLO2011-03-24
809571090221899K100599CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MMOLO2010-04-05
809572033866722K071929NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSALHAW2007-09-19
809571116330055K071714NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003HAW2007-07-20
809571201047552K070108ELIBRA DYNAMIC KNEE BALANCERONN2007-04-04
809571613882857K060336NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002HAW2006-04-28
809571160728408K041369NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017HAW2004-06-22
809571493643624K032917NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREEHAW2003-10-21
809571720919627K031156NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005HAW2003-05-09
809571145508479K030827NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204HAW2003-05-23
809571457407463K022364NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200HAW2003-02-04
809571719041849K021760NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120HAW2002-08-27
809571849127219K002053NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004HAW2000-08-03
809571241137238
809571271045538
809571403097263
809571508037429
809571706118119
809571808068417

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OLO172026-05-21
HAW102007-09-19
QHE62026-06-04
LLZ42023-05-23
SBF22023-06-13
KWT22019-06-05
JWH22017-12-28
ONN22014-03-21
KWS12013-08-20

PMN#