FDA.reportPublic FDA data

IMASCAP

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30140277363014027736IMASCAP1N2026-01-0165 place Nicolas Copernic PLOUZANE Finistere FR 29280
30140277363014027736IMASCAP1N2020-04-2565 place Nicolas Copernic PLOUZANE Finistere FR 29280

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2922891493146220K253674Blueprint Patient-Specific InstrumentationPHX2026-04-03
2922891713007035K232265BLUEPRINT™ Patient Specific InstrumentationPHX2024-02-21
2922891854973689K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentationPHX2021-11-12
2242321291504827K162800BLUEPRINT Patient Specific InstrumentationKWS2017-02-22
2922891581867396K162800BLUEPRINT Patient Specific InstrumentationKWS2017-02-22
2242321423182976K161789BLUEPRINT Patient Specific InstrumentationKWS2016-12-27
2922891931519231K161789BLUEPRINT Patient Specific InstrumentationKWS2016-12-27
2242321043597710K160555BLUEPRINT Patient Specific InstrumentationKWS2016-06-10
2922891180393385K160555BLUEPRINT Patient Specific InstrumentationKWS2016-06-10
2922891035926974K143374BLUEPRINT Patient Specific InstrumentationKWS2015-04-08
2242321090458764K143374BLUEPRINT Patient Specific InstrumentationKWS2015-04-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWS82017-02-22
PHX32026-04-03