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Omnia Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30105606533010560653Omnia Medical1Y2026-01-016 Canyon Rd MORGANTOWN WV US 26508

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1630211370935351K242431Omnia Medical PsiF DNA™ SystemOUR2025-06-06
1630211158392215K212612Omnia Medical TiBrid-SCOVE2022-11-15
1630211123019883K203207Omnia Medical TiBrid-SAOVD2020-12-23
1630211321515581K192096Omnia Medical Trauma ScrewsHWC2020-02-27
1630211145523969K191778Omnia Medical VBRPLR2019-08-28
1630211449708004K190363Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF CageMAX2020-02-21
1630211249305206K183659Omnia Medical Rotary PLIF SystemMAX2019-02-06
1630211543062232K172323Omnia Medical VBRMQP2017-10-26
1630211060623059K160982Sphynx™KWQ2016-12-22
1630211212300219K130498OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYMBP2013-05-31
1630211845927890K123669TRANSTEK WRIST BLOOD PRESSURE MONITORDXN2012-12-21
1630211762660861K112429GIZA(R) VERTEBRAL BODY REPLACEMENTMQP2012-01-26
1630211221459341
1630211254357056
1630211383731699
1630211478433707
1630211763611022
1630211956245496
1630211995052236
1630212020405012

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX22020-02-21
MQP22017-10-26
OUR12025-06-06
OVE12022-11-15
OVD12020-12-23
HWC12020-02-27
PLR12019-08-28
KWQ12016-12-22
MBP12013-05-31
DXN12012-12-21