OPTIMOTION IMPLANTS, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30164703143016470314OPTIMOTION IMPLANTS, LLC1N2026-01-016052 Turkey Lake Road Suite 170 Orlando FL US 32819

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3500521695416821K240938The Optimotion™ Blue Plus Knee SystemMBH2024-06-27
3500521593784526K220049Optimotion Implants Porous Metal-Backed PatellaMBH2022-03-14
3500521754241838K191084The Optimotion Blue Total Knee SystemMBH2020-04-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBH32024-06-27

PMN#