FDA.report

KYOCERA Medical Corporation Shiga Higashiomi Plant

Matched from indexed company URL: KYOCERA CORPORATION

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30065364543006536454KYOCERA Medical Corporation Shiga Higashiomi Plant1N2026-01-0110-1 KAWAI-CHO Higashiomi-shi Shiga JP 529-1571
30124254193010566635KYOCERA Medical Corporation1N2026-01-016 Takeda Tobadono-cho, Fushimi-ku Kyoto JP 612-8450
30153983193007932279Kyocera Medical Technologies, Inc.1Y2026-01-011289 Bryn Mawr Ave Ste A Redlands CA US 92374

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2277281592640516K250486Skyway Anterior Cervical Plate SystemKWQ2025-04-10
678551018706057K243444BIOCERAM AZUL® HEADLZO2024-12-05
2035771018706057K243444BIOCERAM AZUL® HEADLZO2024-12-05
2277281420845223K243015Skyway Anterior Cervical Plate SystemKWQ2024-11-05
2277281042861258K242771Tesera-k PL System and Tesera-k XL SystemMAX2025-03-20
2277281762292008K242045Initia T3 Acetabular Hemispherical Shell SystemLPH2025-04-10
2277281413388582K232114TRIBRID® Unicompartmental Knee SystemHSX2024-04-04
2277281081031820K231766Skyway Anterior Cervical Plate SystemKWQ2023-09-12
2277281078061612K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemOVD2023-04-21
2277281796614569K223105Tesera-K SC SystemOVE2022-12-22
2277281408170740K212980Tesera-k ALIF SystemOVD2022-01-07
2277281307525198K212070KMTI S141 Lumbar Interbody Fusion SystemMAX2021-08-30
2277282056643670K200709Kyocera Bipolar Hip SystemKWY2020-04-17
2277281999441785K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemOQG2020-03-11
2277281113870640K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemOVD2020-02-04
2277281265376638K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemJWH2019-06-20
2277281038083288K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemOVD2018-12-07
2277281613852563K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemMAX2018-09-11
2277281431390705K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemOVD2018-06-14
2277282014560057K171543Renovis Surgical Hip Replacement SystemOQG2017-11-16
2277281984672345K170888Renovis S141 Lumbar Interbody Fusion SystemMAX2017-08-08
678551369568277K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADLZO2016-11-01
2035771369568277K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADLZO2016-11-01
678551543586752K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADLZO2016-11-01
2035771543586752K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADLZO2016-11-01
2277281980128499K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemOVE2016-03-16
2277281551665993K152193Renovis Anterior Cervical Plate SystemKWQ2015-09-25
2277281253375483K143647Renovis Surgical Hip Replacement SystemOQG2015-05-11
2277281920114751K143126Renovis S141 Lumbar Interbody Cage SystemMAX2015-02-06
2277281729996502K142095RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMOVD2014-10-15
2277281279413707K141676RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEMLPH2014-11-04
2277281932013876K141370RENOVIS CEMENTED HIP SYSTEMJDI2014-09-02
2277281658850338K140106S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMOVD2014-03-27
2277282016298180K132312RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEMLPH2014-04-11
2277281953251308K131354RENOVIS BIPOLAR HIP SYSTEMKWY2013-09-19
2277281759375084K131122S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMOVD2013-09-18
2277281383110416K120038A200 KNEE SYSTEMOIY2013-02-14
2277281957221467K113084RENOVIS CANNULATED SCREW SYSTEMHWC2011-12-09
2277281100832600K112897RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESISOQG2012-06-13
2277281367554043K111940S 100 PEDICLE SCREW SYSTEMMNH2012-05-15
2277281743211407K110965RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEMKTT2011-05-11
2277281197538934K101682S 100 PEDICLE SCREW SYSTEMMNI2010-12-07
2277281495645789K092082SYNERGY CANNULATED SCREW SYSTEMHWC2009-10-02
2035771170204229
678551059512436
678551084631249
2277281258244035
678551385453491
678551557473161
678551563775742
678551663584599
678551824424778
678551865436703
678551937440779

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
OVD82023-04-21
LZO62024-12-05
MAX52025-03-20
KWQ42025-04-10
OQG42020-03-11
LPH32025-04-10
OVE22022-12-22
KWY22020-04-17
HWC22011-12-09
HSX12024-04-04
JWH12019-06-20
JDI12014-09-02
OIY12013-02-14
MNH12012-05-15
KTT12011-05-11
MNI12010-12-07

PMN

CERAPEARL

1986-02-21

KYOCERA INTERNATIONAL, INC.

GUDID

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