Kyocera Corp Shiga Gamo Plant

FDA Filings

This page includes the latest FDA filings for Kyocera Corp Shiga Gamo Plant. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3006536454
• FEI Number: 3006536454
• Name: KYOCERA Corporation Shiga Gamo Plant
• Owner & Operator: KYOCERA Corporation
• Contact Address: 3-3-31 Miyahara, Yodogawa-ku --; Osaka JP-NOTA 532-0003 JP
• Official Correspondent:
  • Masato - Atsumi
  • 81-6-71757702-x
• US Agent:
  • Cheryl Hastings
  • Hastings Regulatory Consulting, LLC
  • 574 5274220
  • Cheryl-Hastings@comcast.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 10-1 KAWAI-CHO Higashiomi-shi; Shiga Siga, 529-1595 JP
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K082924 | KWA KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	DYNASTY ACETABULAR SYSTEM 50mm and 54mm Alumina Ceramic Femoral Heads	2011-05-24
PMN K082924 | JDL KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	DYNASTY ACETABULAR SYSTEM 50mm and 54mm Alumina Ceramic Femoral Heads	2011-05-24
PMN K100008 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	CARDO MEDICAL CERAMIC HIP SYSTEM 32mm and 36mm Alumina Ceramic Femoral Heads	2011-05-09
PMN K072656 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	DYNASTY CERAMIC FEMORAL HEAD 44 and 48mm Alumina Ceramic Femoral Heads	2010-02-18
PMN K072656 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	DYNASTY CERAMIC FEMORAL HEAD 28,32,36,38,40,42 and 46mm Alumina Ceramic Femoral Heads	2010-02-18
PMN K920290 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	KINAMED 32MM BIOCERAM-Z TOTAL HIP FEMORAL BALL	2007-02-01
PMN K920219 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	KINAMED 26MM BIOCERAM-Z TOTAL HIP FEMORAL BALL	2007-02-01
PMN K915310 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL	2007-02-01
PMN K915309 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL	2007-02-01
PMN K894904 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	KINAMED CERAMIC ATH TOTAL HIP -28MM BALL	2007-02-01
PMN K890472 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	ATH CERAMIC UHMWPE TOTAL HIP SYSTEM KINAMED 32MM BIOCERAM-Z TOTAL HIP BALL	2007-02-01