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 Number3014174782
FEI Number3014174782
NameSelenium America Inc.
Owner & OperatorSelenium Medical S.A.S.
Contact AddressZ.I Chef de Baie 40 rue Chef de Baie
La Rochelle FR-17 Charente-Maritime 17000 FR
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address6201 Fairview Road Suite 200
Charlotte, NC 28210 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number1000461041
FEI Number1000461041
NameDavid Lennarz
Owner & OperatorSelenium Medical S.A.S.
Contact AddressZ.I Chef de Baie 40 rue Chef de Baie
La Rochelle FR-17 Charente-Maritime 17000 FR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address144 Research Drive
Hampton, VA 23666 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Selenium America Inc. [Selenium Medical S.A.S.]
Czar Anterior Plate System2020-02-14
David Lennarz [Selenium Medical S.A.S.]
Centrolock2020-01-08
David Lennarz [Selenium Medical S.A.S.]
INCORE LAPIDUS SYSTEM2019-07-22
David Lennarz [Selenium Medical S.A.S.]
Xultan 5.5 Pedicle Screw System2019-07-22
David Lennarz [Selenium Medical S.A.S.]
AXI+LINE2019-07-22
David Lennarz [Selenium Medical S.A.S.]
AXI+LINE2019-07-22
David Lennarz [Selenium Medical S.A.S.]
MEDIANT2018-05-28
David Lennarz [Selenium Medical S.A.S.]
IN2BONES FRACTURE AND CORRECTION SYSTEM2018-05-28
David Lennarz [Selenium Medical S.A.S.]
IN2BONES FRACTURE AND CORRECTION SYSTEM2018-05-28
David Lennarz [Selenium Medical S.A.S.]
SICAGE SYSTEM2018-05-28
David Lennarz [Selenium Medical S.A.S.]
COLINK PLATING SYSTEM2018-05-28
David Lennarz [Selenium Medical S.A.S.]
COLINK PLATING SYSTEM2018-05-28
David Lennarz [Selenium Medical S.A.S.]
REVOLUTION SPINAL SYSTEM2018-05-28
David Lennarz [Selenium Medical S.A.S.]
LIBRA2018-05-28
David Lennarz [Selenium Medical S.A.S.]
LIBRA2018-05-28
David Lennarz [Selenium Medical S.A.S.]
LIBRA2018-05-28
David Lennarz [Selenium Medical S.A.S.]
AYERS ROCK CERVICAL INTERBODY FUSION SYSTEM2018-05-28
David Lennarz [Selenium Medical S.A.S.]
SNIPER STAPLE2018-05-28
David Lennarz [Selenium Medical S.A.S.]
MONT BLANC SPINAL SYSTEMS AND MONT BLANC MIS SPINAL SYSTEMS2018-05-28
David Lennarz [Selenium Medical S.A.S.]
MONT BLANC SPINAL SYSTEMS AND MONT BLANC MIS SPINAL SYSTEMS2018-05-28
David Lennarz [Selenium Medical S.A.S.]
MONT BLANC SPINAL SYSTEMS AND MONT BLANC MIS SPINAL SYSTEMS2018-05-28
David Lennarz [Selenium Medical S.A.S.]
MONT BLANC SPINAL SYSTEMS AND MONT BLANC MIS SPINAL SYSTEMS2018-05-28
David Lennarz [Selenium Medical S.A.S.]
MONT BLANC SPINAL SYSTEMS AND MONT BLANC MIS SPINAL SYSTEMS2018-05-28
David Lennarz [Selenium Medical S.A.S.]
TWIN PEAKS LUMBAR INTERBODY FUSION SYSTEM2018-05-28
David Lennarz [Selenium Medical S.A.S.]
MOTOBAND2018-05-28
David Lennarz [Selenium Medical S.A.S.]
MOTOBAND2018-05-28
David Lennarz [Selenium Medical S.A.S.]
CrossTie2018-05-28
David Lennarz [Selenium Medical S.A.S.]
REVOLUTION SPINAL SYSTEM2018-05-28
David Lennarz [Selenium Medical S.A.S.]
CrossRoads Reamer Sterile2018-05-28
David Lennarz [Selenium Medical S.A.S.]
CrossTie2018-05-28
David Lennarz [Selenium Medical S.A.S.]
REDUCE FRACTURE PLATING SYSTEM VIEW PLATING SYSTEM2018-05-28
David Lennarz [Selenium Medical S.A.S.]
REDUCE FRACTURE PLATING SYSTEM VIEW PLATING SYSTEM2018-05-28
David Lennarz [Selenium Medical S.A.S.]
TOEGRIP2018-05-28
David Lennarz [Selenium Medical S.A.S.]
BITE COMPRESSION SCREWS2018-05-28
David Lennarz [Selenium Medical S.A.S.]
HAMMER TOE REAMING IMPLANT SYSTEM (HTR) TRILLIANT K-WIRE2018-05-28
David Lennarz [Selenium Medical S.A.S.]
NUVASIVE VUEPOINT II OCT SYSTEM2018-04-12
David Lennarz [Selenium Medical S.A.S.]
NUVASIVE RELINE SYSTEM2018-04-12
David Lennarz [Selenium Medical S.A.S.]
Airlock2018-01-09
David Lennarz [Selenium Medical S.A.S.]
Airlock2018-01-09
David Lennarz [Selenium Medical S.A.S.]
Nexis2018-01-09
David Lennarz [Selenium Medical S.A.S.]
Nexis2018-01-09
David Lennarz [Selenium Medical S.A.S.]
Lync2018-01-09
David Lennarz [Selenium Medical S.A.S.]
Arcad2018-01-09
David Lennarz [Selenium Medical S.A.S.]
Novastep2018-01-09
David Lennarz [Selenium Medical S.A.S.]
Novastep2018-01-09
David Lennarz [Selenium Medical S.A.S.]
Bone Fixation Plate2013-10-28

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