KYOCERA Medical Corporation Shiga Higashiomi Plant

FDA Device Registration & Listing · Higashiomi-shi Shiga, JP · Registration 3006536454

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006536454
FEI Number
3006536454
Entity Name
KYOCERA Medical Corporation Shiga Higashiomi Plant
City/State/Country
Higashiomi-shi Shiga, JP
Establishment Address
10-1 KAWAI-CHO, Higashiomi-shi Shiga 529-1571, JP
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
KYOCERA Medical Corporation (Owner Number: 9097359)
Owner / Operator Contact Address
6 Takeda Tobadono-cho, Fushimi-ku, --, Kyoto, JP-NOTA 612-8450, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

KINAMED 26MM BIOCERAM-Z TOTAL HIP FEMORAL BALL DYNASTY ACETABULAR SYSTEM 50mm and 54mm Alumina Ceramic Femoral Heads CARDO MEDICAL CERAMIC HIP SYSTEM 32mm and 36mm Alumina Ceramic Femoral Heads KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL ATH CERAMIC UHMWPE TOTAL HIP SYSTEM KINAMED 32MM BIOCERAM-Z TOTAL HIP BALL DYNASTY CERAMIC FEMORAL HEAD 28,32,36,38,40,42 and 46mm Alumina Ceramic Femoral Heads DYNASTY CERAMIC FEMORAL HEAD 44 and 48mm Alumina Ceramic Femoral Heads KINAMED 32MM BIOCERAM-Z TOTAL HIP FEMORAL BALL KINAMED CERAMIC ATH TOTAL HIP -28MM BALL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2017-01-11
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2017-01-11
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2007-02-01
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Orthopedic Class 3 888.3320 2011-05-24
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2011-05-24
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-12-17
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2011-05-09
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2007-02-01
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2017-01-11
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2017-01-11
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2007-02-01
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2010-02-18
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2007-02-01
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2007-02-01

Official Correspondent

Masato Atsumi

US Agent Details

Cheryl Hastings Business: Hastings Regulatory Consulting, LLC Email: Cheryl-Hastings@comcast.net Phone: (574) 5274220

Related Public Records

Same Entity

KYOCERA Medical Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012119238 KYOCERA Medical Corporation Shiga Yasu Plant Yasu-shi Shiga, JP
3012425419 KYOCERA Medical Corporation Kyoto, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K860442 Howmedica Corp. PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259 1986-05-06
K973124 Sulzer Orthopedics, Inc. APR POROUS HA HIP SYSTEM 1997-11-03
K030151 Hayes Medical, Inc. CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM 2003-04-10
K153381 Corin U.S.A. Limited Corin Metafix Hip Stem 2016-01-21
K140975 Lima Corporate S.P.A. MASTERSL FEMORAL STEM 2014-06-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006536454. Last updated year: 2026. Please use registration number 3006536454 when referencing this establishment in official correspondence.
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