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 Number: 3001278222
• FEI Number: 3001278222
• Name: Lindsay Stafford
• Owner & Operator: CeramTec GmbH
• Contact Address: CeramTec-Platz 1-9 ; Stuttgart DE-BW Baden-Wurttemberg D-73207 DE
• Official Correspondent:
  • Stefan - Ruck
  • 049-7153-611-10506
• US Agent:
  • Lindsay Stafford
  • CeramTec
  • 864 6842253
  • l.stafford@ceramtec.de
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1350 N Santorini Dr ; Warsaw, IN 46580 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 8044172
• FEI Number: 3002806653
• Name: Lindsay Stafford
• Owner & Operator: CeramTec GmbH
• Contact Address: CeramTec-Platz 1-9 ; Stuttgart DE-BW Baden-Wurttemberg D-73207 DE
• Official Correspondent:
  • Stefan - Ruck
  • 049-7153-611-10506
• US Agent:
  • Lindsay Stafford
  • CeramTec
  • 864 6842253
  • l.stafford@ceramtec.de
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1350 N Santorini Dr ; Warsaw, IN 46580 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMA P010001S024 CERAMTEC GMBH	Transcend Hip Articulation System	2021-10-07
PMA P010001S023 CERAMTEC GMBH	Transcend Hip Articulation System	2021-06-30
PMA P010001S022 CERAMTEC GMBH	CERAMIC TRANSCEND HIP ARTICULATION SYSTEM	2020-01-22
PMA P010001S020 CERAMTEC GMBH	Transcend Hip Articulation System	2019-08-09
PMA P010001S019 CERAMTEC GMBH	TRANSCEND Hip Articulation System	2019-03-06
PMA P010001S018 CERAMTEC GMBH	Transcend Hip Articulation System	2018-04-20
PMA P010001S016 CERAMTEC GMBH	TRANSCEND HIP ARTICULATION SYSTEM	2016-02-25
PMA P010001S015 CERAMTEC GMBH	TRANSCEND HIP ARTICULATION SYSTEM	2016-02-25
PMA P010001S017 CERAMTEC GMBH	TRANSCEND HIP ARTICULATION SYSTEM	2016-02-24
PMA P010001S014 CERAMTEC GMBH	TRANSCEND HIP ARTICULATION SYSTEM	2015-12-04
PMA P010001S013 CERAMTEC GMBH	TRANSCEND HIP ARTICULATION SYSTEM	2015-06-19
PMA P010001S012 CERAMTEC GMBH	TRANSCEND HIP ARTICULATION SYSTEM	2015-06-11
PMA P010001S011 CERAMTEC GMBH	TRANSCEND HIP ARTICULATION SYSTEM	2015-03-25
PMA P010001S009 CERAMTEC GMBH	CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM	2012-04-19
PMA P010001S010 CERAMTEC GMBH	TRANSCEND HIP ARTICULATION SYSTEM	2012-02-14
PMA P010001S008 CERAMTEC GMBH	CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM	2011-02-25
PMA P010001S007 CERAMTEC GMBH	CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM	2010-09-15
PMA P010001S006 CERAMTEC GMBH	CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM	2010-09-15
PMA P010001S005 CERAMTEC GMBH	CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM	2010-07-06
PMA P010001S003 CERAMTEC GMBH	CERAMIC TRANSCEND HIP ARTICULATION SYSTEM	2008-07-03
PMA P010001S004 CERAMTEC GMBH	CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM	2007-08-17
PMA P010001S002 CERAMTEC GMBH	CERAMIC TRANSCEND HIP ARTICULATION SYSTEM	2005-12-12
PMA P010001S001 CERAMTEC GMBH	CERAMIC TRANSCEND HIP ARTICULATION SYSTEM	2003-04-04
PMA P010001 CERAMTEC GMBH	CERAMIC TRANSCEND HIP ARTICULATION SYSTEM	2003-02-03

Similar & Related FDA Registered Companies

• CERAMTEC GMBHceramtec-platz 1-973207plochingen 73207 PMA NumberP010001 Supplement NumberS025 Date Received06/21/2022 Decision Date07/20/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092965844	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ROD RUBALIT 708 INVOICE 5640013626 HS-CODE 85471000 HBL BANQBRE4466377 . . .	1 PKG
2020092678106	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	STATIONARY DISC MADE OF REBALIT HS-CODE 690919 HBL BANQBRE4509189 . . .	1 PKG
2020092655148	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	SUBSTRATE RUBALIT 708 S HS-CODE 854710 HBL BANQBRE4454017 NOT STACKABLE . . .	3 PKG
2020092562667	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	STATIONARY DISC MADE OF REBALIT HS-CODE 690919 HBL BANQBRE4509189 . . .	1 PKG
2020092351652	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	SUBSTRATE RUBALIT 708 S HS-CODE 854710 HBL BANQBRE4454017 NOT STACKABLE . . .	3 PKG
2020091922340	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	SUBSTRATE RUBALIT 708 S INVOICE 5640013401 HS-CODE 854710 HBL BANQBRE4403268 . . .	5 PKG
2020091968524	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	SUBSTRATE RUBALIT 708 S HS-CODE 854710 HBL BANQBRE4454017 NOT STACKABLE . . .	3 PKG
2020091941044	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	9 PACKAGES GRANULAT HS-CODE 28182000	9 PKG