Selenium Medical S A S

FDA Filings

This page includes the latest FDA filings for Selenium Medical S A S. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3014174782
• FEI Number: 3014174782
• Name: Selenium America Inc.
• Owner & Operator: Selenium Medical S.A.S.
• Contact Address: Z.I Chef de Baie 40 rue Chef de Baie ; La Rochelle FR-17 Charente-Maritime 17000 FR
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 6201 Fairview Road Suite 200; Charlotte, NC 28210 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 1000461041
• FEI Number: 1000461041
• Name: David Lennarz
• Owner & Operator: Selenium Medical S.A.S.
• Contact Address: Z.I Chef de Baie 40 rue Chef de Baie ; La Rochelle FR-17 Charente-Maritime 17000 FR
• US Agent:
  • David Lennarz
  • Registrar Corp
  • 757 2240177
  • 757 2240179
  • david.lennarz@registrarcorp.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 144 Research Drive ; Hampton, VA 23666 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K180772 | KWQ Selenium America Inc. [Selenium Medical S.A.S.]	Czar Anterior Plate System	2020-02-14
PMN K192356 | HRS David Lennarz [Selenium Medical S.A.S.]	Centrolock	2020-01-08
PMN K180257 | HWC David Lennarz [Selenium Medical S.A.S.]	INCORE LAPIDUS SYSTEM	2019-07-22
PMN K170108 | NKB David Lennarz [Selenium Medical S.A.S.]	Xultan 5.5 Pedicle Screw System	2019-07-22
PMN K152548 | HWC David Lennarz [Selenium Medical S.A.S.]	AXI+LINE	2019-07-22
PMN K152548 | HRS David Lennarz [Selenium Medical S.A.S.]	AXI+LINE	2019-07-22
PMN K173935 | KWQ David Lennarz [Selenium Medical S.A.S.]	MEDIANT	2018-05-28
PMN K170518 | HWC David Lennarz [Selenium Medical S.A.S.]	IN2BONES FRACTURE AND CORRECTION SYSTEM	2018-05-28
PMN K170518 | HRS David Lennarz [Selenium Medical S.A.S.]	IN2BONES FRACTURE AND CORRECTION SYSTEM	2018-05-28
PMN K170475 | OUR David Lennarz [Selenium Medical S.A.S.]	SICAGE SYSTEM	2018-05-28
PMN K163293 | HWC David Lennarz [Selenium Medical S.A.S.]	COLINK PLATING SYSTEM	2018-05-28
PMN K163293 | HRS David Lennarz [Selenium Medical S.A.S.]	COLINK PLATING SYSTEM	2018-05-28
PMN K163056 | NKB David Lennarz [Selenium Medical S.A.S.]	REVOLUTION SPINAL SYSTEM	2018-05-28
PMN K162750 | NKB David Lennarz [Selenium Medical S.A.S.]	LIBRA	2018-05-28
PMN K162750 | MNI David Lennarz [Selenium Medical S.A.S.]	LIBRA	2018-05-28
PMN K162750 | MNH David Lennarz [Selenium Medical S.A.S.]	LIBRA	2018-05-28
PMN K162694 | ODP David Lennarz [Selenium Medical S.A.S.]	AYERS ROCK CERVICAL INTERBODY FUSION SYSTEM	2018-05-28
PMN K162354 | JDR David Lennarz [Selenium Medical S.A.S.]	SNIPER STAPLE	2018-05-28
PMN K161387 | OSH David Lennarz [Selenium Medical S.A.S.]	MONT BLANC SPINAL SYSTEMS AND MONT BLANC MIS SPINAL SYSTEMS	2018-05-28
PMN K161387 | NKB David Lennarz [Selenium Medical S.A.S.]	MONT BLANC SPINAL SYSTEMS AND MONT BLANC MIS SPINAL SYSTEMS	2018-05-28
PMN K161387 | MNI David Lennarz [Selenium Medical S.A.S.]	MONT BLANC SPINAL SYSTEMS AND MONT BLANC MIS SPINAL SYSTEMS	2018-05-28
PMN K161387 | MNH David Lennarz [Selenium Medical S.A.S.]	MONT BLANC SPINAL SYSTEMS AND MONT BLANC MIS SPINAL SYSTEMS	2018-05-28
PMN K161387 | KWP David Lennarz [Selenium Medical S.A.S.]	MONT BLANC SPINAL SYSTEMS AND MONT BLANC MIS SPINAL SYSTEMS	2018-05-28
PMN K152355 | MAX David Lennarz [Selenium Medical S.A.S.]	TWIN PEAKS LUMBAR INTERBODY FUSION SYSTEM	2018-05-28
PMN K152306 | HWC David Lennarz [Selenium Medical S.A.S.]	MOTOBAND	2018-05-28
PMN K152306 | HRS David Lennarz [Selenium Medical S.A.S.]	MOTOBAND	2018-05-28
PMN K143039 | HWC David Lennarz [Selenium Medical S.A.S.]	CrossTie	2018-05-28
PMN K142929 | GEI David Lennarz [Selenium Medical S.A.S.]	REVOLUTION SPINAL SYSTEM	2018-05-28
PMN K142727 | JDR David Lennarz [Selenium Medical S.A.S.]	CrossRoads Reamer Sterile	2018-05-28
PMN K141857 | HWC David Lennarz [Selenium Medical S.A.S.]	CrossTie	2018-05-28
PMN K140876 | HWC David Lennarz [Selenium Medical S.A.S.]	REDUCE FRACTURE PLATING SYSTEM VIEW PLATING SYSTEM	2018-05-28
PMN K140876 | HRS David Lennarz [Selenium Medical S.A.S.]	REDUCE FRACTURE PLATING SYSTEM VIEW PLATING SYSTEM	2018-05-28
PMN K133477 | HTY David Lennarz [Selenium Medical S.A.S.]	TOEGRIP	2018-05-28
PMN K132893 | HWC David Lennarz [Selenium Medical S.A.S.]	BITE COMPRESSION SCREWS	2018-05-28
PMN K121008 | HTY David Lennarz [Selenium Medical S.A.S.]	HAMMER TOE REAMING IMPLANT SYSTEM (HTR) TRILLIANT K-WIRE	2018-05-28
PMN K180198 | KWP David Lennarz [Selenium Medical S.A.S.]	NUVASIVE VUEPOINT II OCT SYSTEM	2018-04-12
PMN K143684 | KWP David Lennarz [Selenium Medical S.A.S.]	NUVASIVE RELINE SYSTEM	2018-04-12
PMN K151277 | HRS David Lennarz [Selenium Medical S.A.S.]	Airlock	2018-01-09
PMN K143523 | HRS David Lennarz [Selenium Medical S.A.S.]	Airlock	2018-01-09
PMN K143229 | HWC David Lennarz [Selenium Medical S.A.S.]	Nexis	2018-01-09
PMN K143146 | HWC David Lennarz [Selenium Medical S.A.S.]	Nexis	2018-01-09
PMN K143049 | HTY David Lennarz [Selenium Medical S.A.S.]	Lync	2018-01-09
PMN K142111 | JDR David Lennarz [Selenium Medical S.A.S.]	Arcad	2018-01-09
LXH David Lennarz [Selenium Medical S.A.S.]	Novastep	2018-01-09
HWE David Lennarz [Selenium Medical S.A.S.]	Novastep	2018-01-09
PMN K083447 | HRS David Lennarz [Selenium Medical S.A.S.]	Bone Fixation Plate	2013-10-28