FDA.reportPublic FDA data

MEDICREA USA CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30057533863005753386MEDICREA USA CORP.1Y2020-04-2550 Greene Street 5th Floor New York NY US 10013

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1115721589530294K191134IB3D ALIFMAX2019-10-30
1115721850391047K190376PASS LP Spinal SystemNKB2019-05-02
1115721186075235K190092UNiD Patient specific 3D printed TLIF cageMAX2019-05-08
1115722028215194K182240PASS LP Spinal SystemNKB2018-10-17
1115721288045535K182158UNiD Patient-matched PLIF cageMAX2019-07-15
1115721128837947K173782UNiD Patient Specific 3D printed cageMAX2018-04-25
1115721404599029K173506LigaPASSOWI2018-04-03
1115721677178577K172021LigaPASSOWI2017-08-30
1115721757960737K170172UNiD Spine AnalyzerLLZ2017-05-24
1115721355302408K163595IMPIX 3D Print CagesMAX2017-11-13
1115721858946425K162786PASS LP Spinal SystemNKB2017-01-25
1115721378810312K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemKWQ2016-12-08
1115721939830443K161149PASS OCT Spinal SystemNKG2016-07-11
1115721630114417

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX52019-10-30
NKB32019-05-02
OWI22018-04-03
LLZ12017-05-24
KWQ12016-12-08
NKG12016-07-11