FDA.reportPublic FDA data

CORENTEC CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30091060923009106092CORENTEC CO., LTD.1N2026-01-0112,Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu, Cheonan Si, Chungnam KR 31056

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1305251538235318K250889EXULT Knee Replacement SystemJWH2025-04-17
1305251295561181K242401EXULT Knee Replacement SystemJWH2024-09-12
1305251628820983K242046EXULT Knee Replacement SystemJWH2024-08-01
1305251352571738K223828BENCOX Delta Option HeadsLZO2023-03-16
1305251990708170K223223BENCOX Mirabo Z Cup CortiniumLPH2023-02-27
1305251032720299K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationJWH2022-08-26
1305251579134443K220468BENCOX Mirabo Cup SystemLPH2022-05-18
1305251599024074K212034LOSPA TKR SystemJWH2021-12-09
1305251184952867K211866Bencox THR SystemLPH2021-07-14
1305251201191700K210614BENCOX Mirabo Z Cup CortiniumLPH2022-05-24
1305252006561547K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightJWH2020-07-30
1305251137238296K200395LOSPA II Knee System (EXULT Knee Replacement System)JWH2020-05-07
1305251375064040K200267LOSPA® IS™ Spinal Fixation SystemNKB2020-03-06
1305251253204243K192507LOSPA II Knee SystemJWH2019-12-11
1305251337543251K182221Bencox Mirabo Cup Multi HoleLPH2019-04-01
1305251238661235K172806Bencox Mirabo Cup SystemLPH2017-10-17
1305251511190850K170243LOSPA IS TLIF & DLIF CagesMAX2017-03-31
1305251976510091K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemLPH2016-12-05
1305251860841236K161641LOSPA IS ACP SystemKWQ2017-01-05
1305251428370699K160157LOSPA Modular Knee SystemJWH2016-12-01
1305251095879154K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone PlugLPH2016-04-29
1305251608593029K151408LOSPA IS Spinal SystemMAX2015-10-02
1305251584763379K150007Modified Bencox Hip SystemLPH2015-05-04
1305251088635416K132644LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BUMNI2013-09-19
1305251788393966K130673LOSPA TOTAL KNEE REPLACEMENT SYSTEMJWH2013-04-15
1305251357106355K122099BENCOX II STEM, BENCOX METAL HEADLPH2012-10-05
1305251457573300K121665BENCOX FORET & BENCOX DELTALZO2012-09-25
1305251658907798K121037LOSPA TIBIAL BASE PLATEJWH2012-05-03
1305251898410045K120924BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUGLPH2012-09-10
1305251652203557K112019BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUPKWY2011-10-12
1305251757923786K110404EAUM TOTAL KNEE SYSTEMJWH2012-02-16
1305251254204101K103431COREN TOTAL HIP SYSTEMLPH2011-07-21
1305251268603796K092076AEGIS & AEGIS II SPINAL SYSTEMMNI2010-04-02
1305251017620836
1305251052480551
1305251077059806
1305251113884178
1305251126457532
1305251141898163
1305251173169352
1305251221733237
1305251294959575
1305251301483280
1305251323131302
1305251327576001
1305251402979885
1305251415001755
1305251436973144
1305251442482203
1305251445929887
1305251448728426
1305251464106073
1305251469138587
1305251472720290
1305251573947934
1305251622718831
1305251626337181
1305251660742555
1305251770985096
1305251778707172
1305251783297808
1305251797177913
1305251826511188
1305251832000884
1305251835156508
1305251842607644
1305251858279144
1305251878881520
1305251917644768
1305251955736223
1305252017595420
1305252063261225
1305252069788299
1305252073430280

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH122025-04-17
LPH122023-02-27
LZO22023-03-16
MAX22017-03-31
MNI22013-09-19
NKB12020-03-06
KWQ12017-01-05
KWY12011-10-12

PMN#