Ceramtec G M B H

FDA Filings

This page includes the latest FDA filings for Ceramtec G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3001278222
FEI Number3001278222
NameLindsay Stafford
Owner & OperatorCeramTec GmbH
Contact AddressCeramTec-Platz 1-9
Stuttgart DE-BW Baden-Wurttemberg D-73207 DE
Official Correspondent
  • Stefan - Ruck
  • 049-7153-611-10506
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1350 N Santorini Dr
Warsaw, IN 46580 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number8044172
FEI Number3002806653
NameLindsay Stafford
Owner & OperatorCeramTec GmbH
Contact AddressCeramTec-Platz 1-9
Stuttgart DE-BW Baden-Wurttemberg D-73207 DE
Official Correspondent
  • Stefan - Ruck
  • 049-7153-611-10506
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1350 N Santorini Dr
Warsaw, IN 46580 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
CERAMTEC GMBH
Transcend Hip Articulation System2021-06-30
CERAMTEC GMBH
CERAMIC TRANSCEND HIP ARTICULATION SYSTEM2020-01-22
CERAMTEC GMBH
Transcend Hip Articulation System2019-08-09
CERAMTEC GMBH
TRANSCEND Hip Articulation System2019-03-06
CERAMTEC GMBH
Transcend Hip Articulation System2018-04-20
CERAMTEC GMBH
TRANSCEND HIP ARTICULATION SYSTEM2016-02-25
CERAMTEC GMBH
TRANSCEND HIP ARTICULATION SYSTEM2016-02-25
CERAMTEC GMBH
TRANSCEND HIP ARTICULATION SYSTEM2016-02-24
CERAMTEC GMBH
TRANSCEND HIP ARTICULATION SYSTEM2015-12-04
CERAMTEC GMBH
TRANSCEND HIP ARTICULATION SYSTEM2015-06-19
CERAMTEC GMBH
TRANSCEND HIP ARTICULATION SYSTEM2015-06-11
CERAMTEC GMBH
TRANSCEND HIP ARTICULATION SYSTEM2015-03-25
CERAMTEC GMBH
CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM2012-04-19
CERAMTEC GMBH
TRANSCEND HIP ARTICULATION SYSTEM2012-02-14
CERAMTEC GMBH
CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM2011-02-25
CERAMTEC GMBH
CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM2010-09-15
CERAMTEC GMBH
CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM2010-09-15
CERAMTEC GMBH
CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM2010-07-06
CERAMTEC GMBH
CERAMIC TRANSCEND HIP ARTICULATION SYSTEM2008-07-03
CERAMTEC GMBH
CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM2007-08-17
CERAMTEC GMBH
CERAMIC TRANSCEND HIP ARTICULATION SYSTEM2005-12-12
CERAMTEC GMBH
CERAMIC TRANSCEND HIP ARTICULATION SYSTEM2003-04-04
CERAMTEC GMBH
CERAMIC TRANSCEND HIP ARTICULATION SYSTEM2003-02-03

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092965844Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyROD RUBALIT 708 INVOICE 5640013626 HS-CODE 85471000 HBL BANQBRE4466377 . . .1 PKG
2020092678106Stadersand,Federal Republic of Germany -> Charleston, South CarolinaSTATIONARY DISC MADE OF REBALIT HS-CODE 690919 HBL BANQBRE4509189 . . .1 PKG
2020092655148Stadersand,Federal Republic of Germany -> Charleston, South CarolinaSUBSTRATE RUBALIT 708 S HS-CODE 854710 HBL BANQBRE4454017 NOT STACKABLE . . .3 PKG
2020092562667Stadersand,Federal Republic of Germany -> Charleston, South CarolinaSTATIONARY DISC MADE OF REBALIT HS-CODE 690919 HBL BANQBRE4509189 . . .1 PKG
2020092351652Stadersand,Federal Republic of Germany -> Charleston, South CarolinaSUBSTRATE RUBALIT 708 S HS-CODE 854710 HBL BANQBRE4454017 NOT STACKABLE . . .3 PKG
2020091922340Stadersand,Federal Republic of Germany -> Charleston, South CarolinaSUBSTRATE RUBALIT 708 S INVOICE 5640013401 HS-CODE 854710 HBL BANQBRE4403268 . . .5 PKG
2020091968524Stadersand,Federal Republic of Germany -> Charleston, South CarolinaSUBSTRATE RUBALIT 708 S HS-CODE 854710 HBL BANQBRE4454017 NOT STACKABLE . . .3 PKG
2020091941044Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina9 PACKAGES GRANULAT HS-CODE 281820009 PKG

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