FDA.reportPublic FDA data

TranS1

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30113020583011302058TranS11N2026-01-0132938 Tamina Rd. Suite 203 Magnolia TX US 77354

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1772062019189666K192792TranS1 AxiaLIF Plus SystemKWQ2019-11-20
1772061282181267K121277Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLEHWC2012-11-07
1772061995252141K102334TRANS1 AXIALIF PLUSKWQ2011-03-14
1772061713531165K092124AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF IIKWQ2010-01-21
1772062010043498K073643TRANS1 AXIALIF 2-LEVEL OR II SYSTEMKWQ2008-04-28
1772061787788378K073515TRANS1 FACET SCREWMRW2008-03-11
1772062066241290K073514TRANS1 AXIAL FIXATON SYSTEMKWQ2008-01-11
1772061344857580K051856TRANS1 FACET SCREWSMRW2005-09-26
1772061147737629K050965TRANS1 AXIALIF SYSTEMKWQ2005-06-14
1772061369177532
1772061034290307

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWQ62019-11-20
MRW32008-03-11
HWC12012-11-07

PMN#