FDA.reportPublic FDA data

OSSEUS FUSION SYSTEMS LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30105310603010531060OSSEUS FUSION SYSTEMS LLC1N2026-01-011931 Greenville Avenue Suite 200 Dallas TX US 75206

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1639831307742056K222107Black Diamond™ POCT Spinal SystemNKG2022-11-03
1639831821048455K213935PISCES-SA Standalone ALIF Interbody SystemOVD2022-05-06
1639831499627656K213590Blue Topaz Sacroiliac Screw SystemOUR2022-03-01
1639831754520402K192495Black Diamond Navigation InstrumentsOLO2020-01-17
1639831018249322K192121Black Diamond Pedicle Screw SystemNKB2019-10-29
1639831678353354K181881Outlet Sacroiliac Joint Fusion SystemOUR2018-10-03
1639831929863423K181347Aries® Lumbar InterbodiesMAX2018-08-15
1639831464625007K170844Gemini-C Hybrid Cervical Interbody SystemODP2017-07-03
1639832023239115K160522White Pearl Preferred Angle Anterior Cervical PlateKWQ2016-04-26
1639831590266329K131810OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEMMNH2013-08-08
1639831050605366
1639831053723355
1639831057015072
1639831102654681
1639831155882589
1639831212467012
1639831221300556
1639831320883130
1639831485787803
1639831519051754
1639831620587424
1639831621770648
1639831632017673
1639831633989725
1639831655562194
1639831695158558
1639831701399396
1639831794106336
1639831802131824
1639831864586274
1639831911260584
1639831918601293
1639831967221744
1639831969753282
1639832031513635

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OUR22022-03-01
NKG12022-11-03
OVD12022-05-06
OLO12020-01-17
NKB12019-10-29
MAX12018-08-15
ODP12017-07-03
KWQ12016-04-26
MNH12013-08-08