FDA.reportPublic FDA data

OrthoSensor, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30085927153008592715OrthoSensor, Inc.1N2020-04-251855 Griffin Road Suite A-310 Dania Beach FL US 33004

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1200891581241714K200665VERASENSE for Stryker TriathlonONN2020-04-12
1200891570258089K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 LeftONN2020-04-01
1200891030122996K180459VERASENSE for Zimmer Biomet PersonaONN2018-06-07
1200891158401483K150372VERASENSE Knee SystemONN2016-04-15
1200891881030855
1200892066734575

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ONN42020-04-12

PMN#

GUDID#

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