FDA.reportPublic FDA data

XENIX MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30124292893012429289XENIX MEDICAL1N2026-01-01149 W Michigan St Orlando FL US 32806

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1943841702403991K253583LUX Expandable Lumbar Interbody SystemMAX2026-02-23
1943841687225179K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsNKB2025-06-12
1943841449557639K233241SOLACE Sacroiliac Fixation SystemOUR2023-10-27
1943841987140040K231829Xenix Medical Sacroiliac Fixation SystemOUR2023-08-15
1943841405771262K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalODP2023-09-01
1943841187717394K182210TiWAVE-L Porous Titanium Lumbar CageMAX2019-01-07
1943841011692255K180401TiWAVE-C™ Porous Titanium Cervical CageODP2018-06-14
1943841189485351K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyODP2017-07-12
1943841817504126K153615NeoFuse HA Enhanced PLIF/TLIFMAX2016-05-06
1943841005550609
1943841249297615
1943841352136034
1943841371378094
1943841472273178
1943841540832309
1943841544803971
1943841610782183
1943841873330589
1943841920157155
1943841920494925
1943841934178213

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX32026-02-23
ODP32023-09-01
OUR22023-10-27
NKB12025-06-12

PMN#

GUDID#

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