Cea Saclay

FDA Filings

This page includes the latest FDA filings for Cea Saclay. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010657154
• FEI Number: 3010657154
• Name: SECR/LABRA
• Owner & Operator: CEA / SACLAY
• Contact Address: 91191 Gif sur Yvette cedex ; Gif sur Yvette FR-NOTA 91191 FR
• Official Correspondent:
  • Christophe Poussard
  • 33-1-69089166-x
• US Agent:
  • Michael van der Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: centre du CEA/SACLAY ; Gif sur Yvette Ile-de-France, 91191 FR
• Establishment Type: Sterilize Medical Device for Another Party (Contract Sterilizer)

FDA Filings

Device Company	Device	Date
PMN K150568 | PHX SECR/LABRA [CEA / SACLAY]	ARROW? Humeral stem	2016-12-13
PMN K150568 | KWT SECR/LABRA [CEA / SACLAY]	ARROW? Humeral stem	2016-12-13
PMN K150568 | HSD SECR/LABRA [CEA / SACLAY]	ARROW? Humeral stem	2016-12-13
PMN K150471 | HSB SECR/LABRA [CEA / SACLAY]	CALCANAIL? nail 12 and screws	2016-12-13
PMN K150463 | HSB SECR/LABRA [CEA / SACLAY]	CALCANAIL? nail 10 and screws	2016-12-13
PMN K142778 | PHX SECR/LABRA [CEA / SACLAY]	ARROW? metal-back glenoid base	2016-12-13
HWE SECR/LABRA [CEA / SACLAY]	CoLS? instruments	2016-12-13
HWE SECR/LABRA [CEA / SACLAY]	BE POD? Burs	2016-12-13
HWE SECR/LABRA [CEA / SACLAY]	ARROW? instruments	2016-12-13
PMN K964878 | MEH SECR/LABRA [CEA / SACLAY]	ESOP S/C FEMORAL STEM	2014-01-03
PMN K964878 | LZO SECR/LABRA [CEA / SACLAY]	ESOP S/C FEMORAL STEM	2014-01-03
PMN K961388 | MEH SECR/LABRA [CEA / SACLAY]	ATLAS III ACETABULAR CUP	2014-01-03
PMN K120740 | MBI SECR/LABRA [CEA / SACLAY]	COLS? FIXATION SYSTEM	2014-01-03
PMN K113591 | HWC SECR/LABRA [CEA / SACLAY]	COLS PEEK	2014-01-03
PMN K112193 | KWT SECR/LABRA [CEA / SACLAY]	ARROW REVERSE SHOULDER SYSTEM	2014-01-03
PMN K112193 | KWS SECR/LABRA [CEA / SACLAY]	ARROW REVERSE SHOULDER SYSTEM	2014-01-03
PMN K093599 | KWT SECR/LABRA [CEA / SACLAY]	ARROW ANATOMICAL SHOULDER SYSTEM	2014-01-03
PMN K093599 | KWS SECR/LABRA [CEA / SACLAY]	ARROW ANATOMICAL SHOULDER SYSTEM	2014-01-03
PMN K093599 | HSD SECR/LABRA [CEA / SACLAY]	ARROW ANATOMICAL SHOULDER SYSTEM	2014-01-03
PMN K080974 | MBI SECR/LABRA [CEA / SACLAY]	TLS FIXATION SYSTEM	2014-01-03
PMN K080974 | JDR SECR/LABRA [CEA / SACLAY]	TLS FIXATION SYSTEM	2014-01-03
PMN K080974 | HWC SECR/LABRA [CEA / SACLAY]	TLS FIXATION SYSTEM	2014-01-03
PMN K070617 | HWC SECR/LABRA [CEA / SACLAY]	CANNULATED SCREW	2014-01-03
PMN K060367 | GAT SECR/LABRA [CEA / SACLAY]	TENOLIG	2014-01-03
PMN K052058 | HSB SECR/LABRA [CEA / SACLAY]	TITANIUM TELEGRAPH HUMERAL NAIL	2014-01-03
PMN K050556 | LZO SECR/LABRA [CEA / SACLAY]	ALUMINA HEAD	2014-01-03
PMN K042332 | HSB SECR/LABRA [CEA / SACLAY]	TITANIUM TELEGRAPH HUMERAL NAIL	2014-01-03
PMN K042035 | LZO SECR/LABRA [CEA / SACLAY]	ALUMINA HEAD	2014-01-03
PMN K041456 | HWC SECR/LABRA [CEA / SACLAY]	SNAP-OFF SCREWS	2014-01-03
PMN K033510 | HSB SECR/LABRA [CEA / SACLAY]	TELEGRAPH HUMERAL NAIL	2014-01-03
PMN K023241 | HSB SECR/LABRA [CEA / SACLAY]	TELEGRAPH HUMERAL NAIL	2014-01-03
PMN K021109 | LPH SECR/LABRA [CEA / SACLAY]	ESOP CO-CR FEMORAL HEADS	2014-01-03
PMN K021108 | MEH SECR/LABRA [CEA / SACLAY]	ESOP HA FEMORAL STEM	2014-01-03