Zimmer Biomet Apac Dfe

FDA Filings

This page includes the latest FDA filings for Zimmer Biomet Apac Dfe. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013176080
• FEI Number: 3013176080
• Name: ZIMMER PTE. LTD.
• Owner & Operator: Zimmer Biomet APAC DFE
• Contact Address: 1800 West Center Street ; Warsaw IN 46580 US
• Official Correspondent:
  • Karin Hansen-Wiley
  • 1-574-3732523-x
• US Agent:
  • Holly Seppanen
  • Zimmer Biomet
  • 952 8470494
  • holly.seppanen@zimmerbiomet.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 401 Commonwealth Drive #06-03 How Par Techno Centre; Singapore South East, 149598 SG
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

• Registration Number: 3012725451
• FEI Number: 3012725451
• Name: Holly Seppanen
• Owner & Operator: Zimmer Biomet APAC DFE
• Contact Address: 1800 West Center Street ; Warsaw IN 46580 US
• Official Correspondent:
  • Karin Hansen-Wiley
  • 1-574-3732523-x
• US Agent:
  • Holly Seppanen
  • Zimmer Biomet
  • 952 8470494
  • holly.seppanen@zimmerbiomet.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1800 West Center Street ; Warsaw, IN 46580 US
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
PMN K930554 | JWH ZIMMER PTE. LTD. [Zimmer Biomet APAC DFE]	THE NATURAL-KNEE REVISION	2020-03-10
PMN K821893 | JDI ZIMMER PTE. LTD. [Zimmer Biomet APAC DFE]	ZIMMER METAL BACKED ACETABULAR CUP	2020-03-10
PMN K810520 | KRO ZIMMER PTE. LTD. [Zimmer Biomet APAC DFE]	TIB RET CCK 58WX15HGT	2020-03-05
PMN K992058 | JDI Holly Seppanen [Zimmer Biomet APAC DFE]	Bi-Metric CoCr Head/Neck Replacement Hip Stems	2018-08-14
PMN K171054 | OIY Holly Seppanen [Zimmer Biomet APAC DFE]	Biomet Knee Joint Replacement Prostheses	2018-08-14
PMN K171054 | MBV Holly Seppanen [Zimmer Biomet APAC DFE]	Biomet Knee Joint Replacement Prostheses	2018-08-14
PMN K171054 | MBH Holly Seppanen [Zimmer Biomet APAC DFE]	Biomet Knee Joint Replacement Prostheses	2018-08-14
PMN K171054 | JWH Holly Seppanen [Zimmer Biomet APAC DFE]	Biomet Knee Joint Replacement Prostheses	2018-08-14
PMN K171054 | HRY Holly Seppanen [Zimmer Biomet APAC DFE]	Biomet Knee Joint Replacement Prostheses	2018-08-14
PMN K153657 | OIY Holly Seppanen [Zimmer Biomet APAC DFE]	Vanguard XP Knee System	2018-08-14
PMN K153657 | MBV Holly Seppanen [Zimmer Biomet APAC DFE]	Vanguard XP Knee System	2018-08-14
PMN K153657 | MBH Holly Seppanen [Zimmer Biomet APAC DFE]	Vanguard XP Knee System	2018-08-14
PMN K153657 | JWH Holly Seppanen [Zimmer Biomet APAC DFE]	Vanguard XP Knee System	2018-08-14
PMN K132873 | OIY Holly Seppanen [Zimmer Biomet APAC DFE]	Vanguard XP Knee System	2018-08-14
PMN K132873 | MBV Holly Seppanen [Zimmer Biomet APAC DFE]	Vanguard XP Knee System	2018-08-14
PMN K132873 | MBH Holly Seppanen [Zimmer Biomet APAC DFE]	Vanguard XP Knee System	2018-08-14
PMN K132873 | JWH Holly Seppanen [Zimmer Biomet APAC DFE]	Vanguard XP Knee System	2018-08-14
PMN K121874 | PBI Holly Seppanen [Zimmer Biomet APAC DFE]	G7 Acetabular System	2018-08-14
PMN K121874 | OQI Holly Seppanen [Zimmer Biomet APAC DFE]	G7 Acetabular System	2018-08-14
PMN K121874 | OQH Holly Seppanen [Zimmer Biomet APAC DFE]	G7 Acetabular System	2018-08-14
PMN K121874 | OQG Holly Seppanen [Zimmer Biomet APAC DFE]	G7 Acetabular System	2018-08-14
PMN K121874 | LZO Holly Seppanen [Zimmer Biomet APAC DFE]	G7 Acetabular System	2018-08-14
PMN K121874 | LPH Holly Seppanen [Zimmer Biomet APAC DFE]	G7 Acetabular System	2018-08-14
PMN K121874 | KWZ Holly Seppanen [Zimmer Biomet APAC DFE]	G7 Acetabular System	2018-08-14
PMN K121874 | JDI Holly Seppanen [Zimmer Biomet APAC DFE]	G7 Acetabular System	2018-08-14
PMN K023085 | JDI Holly Seppanen [Zimmer Biomet APAC DFE]	RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM	2018-08-14
JDZ Holly Seppanen [Zimmer Biomet APAC DFE]	BIOMET CEMENT; MIXER	2018-08-14
HWM Holly Seppanen [Zimmer Biomet APAC DFE]	BIOMET OSTEOTOME	2018-08-14
HWA Holly Seppanen [Zimmer Biomet APAC DFE]	BIOMET IMPACTOR	2018-08-14
HTP Holly Seppanen [Zimmer Biomet APAC DFE]	BIOMET FILE	2018-08-14
HTJ Holly Seppanen [Zimmer Biomet APAC DFE]	BIOMET DEPTH; GAUGE; Gauge Biomet Depth	2018-08-14
PMN K120030 | OQG Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Size 4mm and XR 123	2018-08-13
PMN K120030 | MEH Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Size 4mm and XR 123	2018-08-13
PMN K120030 | LZO Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Size 4mm and XR 123	2018-08-13
PMN K120030 | LPH Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Size 4mm and XR 123	2018-08-13
PMN K120030 | KWZ Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Size 4mm and XR 123	2018-08-13
PMN K120030 | KWY Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Size 4mm and XR 123	2018-08-13
PMN K120030 | KWL Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Size 4mm and XR 123	2018-08-13
PMN K120030 | JDI Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Size 4mm and XR 123	2018-08-13
PMN K110400 | OQG Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Microplasty System	2018-08-13
PMN K110400 | MEH Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Microplasty System	2018-08-13
PMN K110400 | LZO Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Microplasty System	2018-08-13
PMN K110400 | LPH Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Microplasty System	2018-08-13
PMN K110400 | KWZ Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Microplasty System	2018-08-13
PMN K110400 | KWY Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Microplasty System	2018-08-13
PMN K110400 | KWL Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Microplasty System	2018-08-13
PMN K110400 | KWA Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Microplasty System	2018-08-13
PMN K110400 | JDL Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Microplasty System	2018-08-13
PMN K110400 | JDI Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete Microplasty System	2018-08-13
PMN K103755 | MEH Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete, Sizes 5mm and 6mm	2018-08-13
PMN K103755 | MAY Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete, Sizes 5mm and 6mm	2018-08-13
PMN K103755 | LZO Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete, Sizes 5mm and 6mm	2018-08-13
PMN K103755 | LWJ Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete, Sizes 5mm and 6mm	2018-08-13
PMN K103755 | LPH Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete, Sizes 5mm and 6mm	2018-08-13
PMN K103755 | KWZ Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete, Sizes 5mm and 6mm	2018-08-13
PMN K103755 | KWY Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete, Sizes 5mm and 6mm	2018-08-13
PMN K103755 | KWL Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete, Sizes 5mm and 6mm	2018-08-13
PMN K103755 | KWA Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete, Sizes 5mm and 6mm	2018-08-13
PMN K103755 | JDL Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete, Sizes 5mm and 6mm	2018-08-13
PMN K103755 | JDI Holly Seppanen [Zimmer Biomet APAC DFE]	Taperloc Complete, Sizes 5mm and 6mm	2018-08-13
PMN K101086 | MEH Holly Seppanen [Zimmer Biomet APAC DFE]	TaperLoc Complete	2018-08-13
PMN K101086 | MAY Holly Seppanen [Zimmer Biomet APAC DFE]	TaperLoc Complete	2018-08-13
PMN K101086 | LZO Holly Seppanen [Zimmer Biomet APAC DFE]	TaperLoc Complete	2018-08-13
PMN K101086 | LWJ Holly Seppanen [Zimmer Biomet APAC DFE]	TaperLoc Complete	2018-08-13
PMN K101086 | LPH Holly Seppanen [Zimmer Biomet APAC DFE]	TaperLoc Complete	2018-08-13
PMN K101086 | KWZ Holly Seppanen [Zimmer Biomet APAC DFE]	TaperLoc Complete	2018-08-13
PMN K101086 | KWY Holly Seppanen [Zimmer Biomet APAC DFE]	TaperLoc Complete	2018-08-13
PMN K101086 | KWL Holly Seppanen [Zimmer Biomet APAC DFE]	TaperLoc Complete	2018-08-13
PMN K101086 | KWA Holly Seppanen [Zimmer Biomet APAC DFE]	TaperLoc Complete	2018-08-13
PMN K101086 | JDL Holly Seppanen [Zimmer Biomet APAC DFE]	TaperLoc Complete	2018-08-13
PMN K101086 | JDI Holly Seppanen [Zimmer Biomet APAC DFE]	TaperLoc Complete	2018-08-13
PMN K090757 | MEH Holly Seppanen [Zimmer Biomet APAC DFE]	Biomet Modular Femoral Revision System	2018-08-13
PMN K090757 | MAY Holly Seppanen [Zimmer Biomet APAC DFE]	Biomet Modular Femoral Revision System	2018-08-13
PMN K090757 | LZO Holly Seppanen [Zimmer Biomet APAC DFE]	Biomet Modular Femoral Revision System	2018-08-13
PMN K090757 | LPH Holly Seppanen [Zimmer Biomet APAC DFE]	Biomet Modular Femoral Revision System	2018-08-13
PMN K090757 | KWZ Holly Seppanen [Zimmer Biomet APAC DFE]	Biomet Modular Femoral Revision System	2018-08-13
PMN K090757 | KWY Holly Seppanen [Zimmer Biomet APAC DFE]	Biomet Modular Femoral Revision System	2018-08-13
PMN K090757 | KWA Holly Seppanen [Zimmer Biomet APAC DFE]	Biomet Modular Femoral Revision System	2018-08-13
PMN K090757 | JDL Holly Seppanen [Zimmer Biomet APAC DFE]	Biomet Modular Femoral Revision System	2018-08-13
PMN K090757 | JDI Holly Seppanen [Zimmer Biomet APAC DFE]	Biomet Modular Femoral Revision System	2018-08-13
PMN K082996 | LZO Holly Seppanen [Zimmer Biomet APAC DFE]	Biolox? delta Option Ceramic Heads	2018-08-13
PMN K062994 | MEH Holly Seppanen [Zimmer Biomet APAC DFE]	Lateralized Taperloc? Microplasty? Femoral Components	2018-08-13
PMN K062994 | MBL Holly Seppanen [Zimmer Biomet APAC DFE]	Lateralized Taperloc? Microplasty? Femoral Components	2018-08-13
PMN K062994 | LZO Holly Seppanen [Zimmer Biomet APAC DFE]	Lateralized Taperloc? Microplasty? Femoral Components	2018-08-13
PMN K062994 | LPH Holly Seppanen [Zimmer Biomet APAC DFE]	Lateralized Taperloc? Microplasty? Femoral Components	2018-08-13
PMN K062994 | KWZ Holly Seppanen [Zimmer Biomet APAC DFE]	Lateralized Taperloc? Microplasty? Femoral Components	2018-08-13
PMN K062994 | KWY Holly Seppanen [Zimmer Biomet APAC DFE]	Lateralized Taperloc? Microplasty? Femoral Components	2018-08-13
PMN K062994 | KWA Holly Seppanen [Zimmer Biomet APAC DFE]	Lateralized Taperloc? Microplasty? Femoral Components	2018-08-13
PMN K062994 | JDL Holly Seppanen [Zimmer Biomet APAC DFE]	Lateralized Taperloc? Microplasty? Femoral Components	2018-08-13
PMN K062994 | JDI Holly Seppanen [Zimmer Biomet APAC DFE]	Lateralized Taperloc? Microplasty? Femoral Components	2018-08-13
PMN K060692 | MBF Holly Seppanen [Zimmer Biomet APAC DFE]	Comprehensive? Primary Shoulder Stems	2018-08-13
PMN K060692 | KWT Holly Seppanen [Zimmer Biomet APAC DFE]	Comprehensive? Primary Shoulder Stems	2018-08-13
PMN K060692 | KWS Holly Seppanen [Zimmer Biomet APAC DFE]	Comprehensive? Primary Shoulder Stems	2018-08-13
PMN K060692 | HSD Holly Seppanen [Zimmer Biomet APAC DFE]	Comprehensive? Primary Shoulder Stems	2018-08-13
PMN K052685 | KRO Holly Seppanen [Zimmer Biomet APAC DFE]	Orthopedic Salvage System - OSS	2018-08-13
PMN K052685 | JDI Holly Seppanen [Zimmer Biomet APAC DFE]	Orthopedic Salvage System - OSS	2018-08-13
PMN K052089 | LZO Holly Seppanen [Zimmer Biomet APAC DFE]	XR-Series Bi-Metric? Femoral Components	2018-08-13
PMN K052089 | LPH Holly Seppanen [Zimmer Biomet APAC DFE]	XR-Series Bi-Metric? Femoral Components	2018-08-13
PMN K052089 | KWZ Holly Seppanen [Zimmer Biomet APAC DFE]	XR-Series Bi-Metric? Femoral Components	2018-08-13
PMN K052089 | KWY Holly Seppanen [Zimmer Biomet APAC DFE]	XR-Series Bi-Metric? Femoral Components	2018-08-13
PMN K052089 | JDI Holly Seppanen [Zimmer Biomet APAC DFE]	XR-Series Bi-Metric? Femoral Components	2018-08-13
PMN K050441 | MEH Holly Seppanen [Zimmer Biomet APAC DFE]	Taper 2? Porous Femoral Stem	2018-08-13
PMN K050441 | MBL Holly Seppanen [Zimmer Biomet APAC DFE]	Taper 2? Porous Femoral Stem	2018-08-13
PMN K050441 | LZY Holly Seppanen [Zimmer Biomet APAC DFE]	Taper 2? Porous Femoral Stem	2018-08-13
PMN K050441 | LZO Holly Seppanen [Zimmer Biomet APAC DFE]	Taper 2? Porous Femoral Stem	2018-08-13
PMN K050441 | LPH Holly Seppanen [Zimmer Biomet APAC DFE]	Taper 2? Porous Femoral Stem	2018-08-13
PMN K050441 | KWZ Holly Seppanen [Zimmer Biomet APAC DFE]	Taper 2? Porous Femoral Stem	2018-08-13
PMN K050441 | KWY Holly Seppanen [Zimmer Biomet APAC DFE]	Taper 2? Porous Femoral Stem	2018-08-13
PMN K050441 | KWB Holly Seppanen [Zimmer Biomet APAC DFE]	Taper 2? Porous Femoral Stem	2018-08-13
PMN K050441 | KWA Holly Seppanen [Zimmer Biomet APAC DFE]	Taper 2? Porous Femoral Stem	2018-08-13
PMN K050441 | JDL Holly Seppanen [Zimmer Biomet APAC DFE]	Taper 2? Porous Femoral Stem	2018-08-13
PMN K050441 | JDI Holly Seppanen [Zimmer Biomet APAC DFE]	Taper 2? Porous Femoral Stem	2018-08-13
FTY Holly Seppanen [Zimmer Biomet APAC DFE]	TAPE, MEASURING, RULERS AND CALIPERS	2018-07-31
PMN K892228 | HRS Holly Seppanen [Zimmer Biomet APAC DFE]	INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM	2018-07-27
PMN K103404 | KWT Holly Seppanen [Zimmer Biomet APAC DFE]	ANA0TOMICAL SHOULDER TM COMBINED SYSTEM	2018-07-27
PMN K103404 | KWS Holly Seppanen [Zimmer Biomet APAC DFE]	ANA0TOMICAL SHOULDER TM COMBINED SYSTEM	2018-07-27
PMN K103404 | HSD Holly Seppanen [Zimmer Biomet APAC DFE]	ANA0TOMICAL SHOULDER TM COMBINED SYSTEM	2018-07-27
KTZ Holly Seppanen [Zimmer Biomet APAC DFE]	CALIPER	2018-07-27
HTC Holly Seppanen [Zimmer Biomet APAC DFE]	PLIERS, SURGICAL	2018-07-27
PMN K003429 | LPH Holly Seppanen [Zimmer Biomet APAC DFE]	MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL	2018-06-01
PMN K020580 | LPH Holly Seppanen [Zimmer Biomet APAC DFE]	X-SERIES BI-METRIC HIP FEMORAL COMPONENTS	2018-05-31
HYA Holly Seppanen [Zimmer Biomet APAC DFE]	Zimmer	2018-05-11
HXW Holly Seppanen [Zimmer Biomet APAC DFE]	BENDER	2018-05-11
HWO Holly Seppanen [Zimmer Biomet APAC DFE]	Zimmer	2018-05-11
HTX Holly Seppanen [Zimmer Biomet APAC DFE]	RONGUER; STRAIGHT	2018-05-11
GDG Holly Seppanen [Zimmer Biomet APAC DFE]	HOOK, SURGICAL, GENERAL & PLASTIC SURGERY	2018-05-11
HTF Holly Seppanen [Zimmer Biomet APAC DFE]	Curette	2018-05-10
HTD Holly Seppanen [Zimmer Biomet APAC DFE]	FORCEPS	2018-05-10
GDH Holly Seppanen [Zimmer Biomet APAC DFE]	Zimmer	2018-05-10
HSO Holly Seppanen [Zimmer Biomet APAC DFE]	Zimmer	2018-04-05