FDA.reportPublic FDA data

Gold Standard Orthopaedics, LLC

Matched from indexed company URL: GOLD STANDARD ORTHOPAEDICS, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30062153903006215390Gold Standard Orthopaedics, LLC1N2020-04-252987 Industrial Parkway Jeffersonville IN US 47130

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
789891908300434K123487GSO GS1 CANNULATED SCREW SYSTEMMNH2013-03-11
789891374116834K110990GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEMKWQ2011-07-25
789891954779445K091359GSO PCT SPINAL SYSTEMKWP2009-09-02
789891992949431K071274GSO GS1 SPACERMQP2007-08-24
789891329687863K070966GSO GS1 SPINAL SYSTEMKWP2007-07-20
789891396450836K063589GSO BONE FIXATION FASTENERSHWC2007-01-31
789891082124702
789891576574102
789891655869414
789891732507588
789891751625173
789891811472569
789891811973226
789891823611078
789891918917488
789892016788830

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWP22009-09-02
MNH12013-03-11
KWQ12011-07-25
MQP12007-08-24
HWC12007-01-31

PMN#