FDA.reportPublic FDA data

MEDICREA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10004322461000432246MEDICREA INTERNATIONAL1N2026-01-015389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes FR 69140
30127721123012772112MEDICREATIONS LLC1Y2026-01-016370 Annie Oakley Dr. Las Vegas NV US 89120
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
2966451948831966K261289UNiD™ Spine Analyzer (SW3002)QIH2026-05-15
2966451322165542K251629UNiD™ Spine AnalyzerQIH2025-08-07
2966451730227813K241164IB3D™ PL Spinal SystemMAX2024-09-06
1993711880173433K231952MEDILIGHTONF2025-09-03
1993711458712048K231950MEDIDIODEGEX2024-08-09
1993711489798474K231948MEDIYAGGEX2024-10-09
2966451403561710K220810Infinity™ OCT System and PASS OCT Spinal SystemNKG2022-04-19
2966451251209817K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemNKB2022-04-08
2966451616130966K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemNKB2022-01-05
2966451606208107K212005UNiD Spine AnalyzerLLZ2022-01-12
2966451579446815K210470C-CURVE Interbody Fusion DeviceOVE2021-09-03
1115721589530294K191134IB3D ALIFMAX2019-10-30
1115721850391047K190376PASS LP Spinal SystemNKB2019-05-02
2966451850391047K190376PASS LP Spinal SystemNKB2019-05-02
1115721186075235K190092UNiD Patient specific 3D printed TLIF cageMAX2019-05-08
2966452028215194K182240PASS LP Spinal SystemNKB2018-10-17
1115722028215194K182240PASS LP Spinal SystemNKB2018-10-17
1115721288045535K182158UNiD Patient-matched PLIF cageMAX2019-07-15
1115721128837947K173782UNiD Patient Specific 3D printed cageMAX2018-04-25
1115721404599029K173506LigaPASSOWI2018-04-03
2966451404599029K173506LigaPASSOWI2018-04-03
1115721677178577K172021LigaPASSOWI2017-08-30
2966451677178577K172021LigaPASSOWI2017-08-30
1115721757960737K170172UNiD Spine AnalyzerLLZ2017-05-24
1115721355302408K163595IMPIX 3D Print CagesMAX2017-11-13
2966451355302408K163595IMPIX 3D Print CagesMAX2017-11-13
2966451858946425K162786PASS LP Spinal SystemNKB2017-01-25
1115721858946425K162786PASS LP Spinal SystemNKB2017-01-25
1115721378810312K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemKWQ2016-12-08
1993711751735724K161926ND YAG Q-switch Laser Therapy MachineGEX2017-02-22
1993711636755033K161925CO2 Laser Therapy MachineGEX2016-10-05
1993711366909075K161692Diode Laser Therapy MachineGEX2016-11-16
1993712012907604K161286IPL Therapy MachineONF2016-08-04
1115721939830443K161149PASS OCT Spinal SystemNKG2016-07-11
2966451544053951K153413PASS LP Spinal SystemNKB2016-04-22
2966451582111233K153169PASS OCT Patient Specific RodsNKG2016-01-29
2966451080868666K150918PASS OCT Spinal SystemNKG2015-10-16
2966451787365715K141398PASS LP SPINAL SYSTEMNKB2015-01-09
2966451501983250K141187IMPIX ALIF S/AOVD2015-01-15
2966451853659753K140738PASS LP SPINAL SYSTEMMNI2014-11-04
2966451794935947K132575PASS LP SPINAL SYSTEMOSH2013-10-03
2966451755739359K132574PASS LP SPINAL SYSTEMOSH2013-11-08
2966451154179084K132395LIGAPASSOWI2013-12-06
2966451826299131K112493PASS LP SPINAL SYSTEMMNI2011-11-21
2966451269576055K100484IMPIX MANTA CERVICAL INTERBODY DEVICEODP2010-03-16
1993711812637800K080382SELLASGEX2008-09-24
2966451363715644K080099PASS SPINAL SYSTEMMNI2008-04-09
2966451608545961K070530MODIFICATION TO PASSMED SPINAL SYSTEMMNH2007-10-18
1115721630114417
2966451021328305
2966451091439111
2966451109075261
2966451147553981
2966451286923865
2966451308954087
2966451355671201
2966451372467489
1993711473509454
2966451476605649
2966451573679896
2966451590419074
1993711636836377
2966451644538247
2966451745917005
2966451758739127
2966451836513885
2966451849143509
2966451967760271
2966451988473669

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB102022-04-08
MAX72024-09-06
GEX62024-10-09
OWI52018-04-03
NKG42022-04-19
MNI32014-11-04
QIH22026-05-15
ONF22025-09-03
LLZ22022-01-12
OSH22013-11-08
OVE12021-09-03
KWQ12016-12-08
OVD12015-01-15
ODP12010-03-16
MNH12007-10-18

PMN#

MEDIYAG

2024-10-09

Medicreations, LLC

IB3D ALIF

2019-10-30

Medicrea International S.A.

LigaPASS

2018-04-03

Medicrea International S.A.

LigaPASS

2017-08-30

Medicrea International S.A.

LigaPASS

2016-09-02

MEDICREA INTERNATIONAL S.A.

LIGAPASS

2013-12-06

MEDICREA INTERNATIONAL

65 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next