FDA.reportPublic FDA data

CETERIX ORTHOPAEDICS, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30091312043009131204CETERIX ORTHOPAEDICS, INC1N2020-04-256500 Kaiser Dr Ste 120 Fremont CA US 94555

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2299731680965259K181772NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)GAT2018-08-01
2299731366134076K180531NovoStitch Pro Meniscal Repair SystemGAT2018-03-29
2299731347507277K143356NovoStitch Plus Meniscal Repair SystemGAT2015-07-21
2299731382865851

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GAT32018-08-01

PMN#