Alpes Cn

FDA Filings

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

FDA Registration(s)

• Registration Number: 3010658151
• FEI Number: 3010658151
• Name: Alpes CN
• Owner & Operator: SPINEART SA
• Contact Address: Chemin du Pre-Fleuri 3 ; Plan-les-Aoutes CH-GE Geneve 1228 CH
• Official Correspondent:
  • Franck PENNESI
  • 041-0-225701200-x
• US Agent:
  • Jerome Trividic
  • SPINEART USA
  • 949 3136400
  • 646 3041001
  • jtrividic@spineart.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Immeuble ABC3, 80 rue Douglas Engelbart, Archamps Technopole,; Archamps Haute-Savoie, 74160 FR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K200312 | ODP Alpes CN [SPINEART SA]	Tryptik Ti	2020-04-07
PMN K193396 | OVD Alpes CN [SPINEART SA]	Perla TL	2020-02-06
PMN K193396 | OSH Alpes CN [SPINEART SA]	Perla TL	2020-02-06
PMN K193396 | NKB Alpes CN [SPINEART SA]	Perla TL	2020-02-06
PMN K193396 | MNI Alpes CN [SPINEART SA]	Perla TL	2020-02-06
PMN K193396 | MNH Alpes CN [SPINEART SA]	Perla TL	2020-02-06
PMN K193396 | KWP Alpes CN [SPINEART SA]	Perla TL	2020-02-06
PMN K192993 | OVD Alpes CN [SPINEART SA]	Scarlet AL-T	2020-01-24
PMN K192993 | MAX Alpes CN [SPINEART SA]	Scarlet AL-T	2020-01-24
PMN K183630 | OLO Alpes CN [SPINEART SA]	Romeo navigation	2019-06-12
HWR Alpes CN [SPINEART SA]	Juliet, Romeo, Tryptik, Perla, Scarlet	2019-06-05
PMN K190877 | OVD Alpes CN [SPINEART SA]	JULIET LL Ti	2019-06-02
PMN K190877 | MAX Alpes CN [SPINEART SA]	JULIET LL Ti	2019-06-02
PMN K190322 | OVE Alpes CN [SPINEART SA]	SCARLET AC-T	2019-03-06
PMN K190322 | ODP Alpes CN [SPINEART SA]	SCARLET AC-T	2019-03-06
PMN K190071 | NKG Alpes CN [SPINEART SA]	PERLA	2019-02-27
PMN K190071 | KWP Alpes CN [SPINEART SA]	PERLA	2019-02-27
PMN K181818 | OVD Alpes CN [SPINEART SA]	Scarlet AL-T	2018-10-10
PMN K181818 | MAX Alpes CN [SPINEART SA]	Scarlet AL-T	2018-10-10
HXB Alpes CN [SPINEART SA]	SCARLET AL-T	2018-10-10
HXW Alpes CN [SPINEART SA]	TRYPTIK	2018-08-01
HXQ Alpes CN [SPINEART SA]	TRYPTIK 2C PLATE	2018-08-01
HTJ Alpes CN [SPINEART SA]	TRYPTIK 2C PLATE	2018-08-01
FTY Alpes CN [SPINEART SA]	TRYPTIK 2C PLATE	2018-08-01
MDM Alpes CN [SPINEART SA]	JULIET	2018-07-27
LWK Alpes CN [SPINEART SA]	JULIET	2018-07-27
GDI Alpes CN [SPINEART SA]	JULIET	2018-07-27
HWE Alpes CN [SPINEART SA]	ROMEO 2	2018-07-23
PMN K181203 | MAX Alpes CN [SPINEART SA]	JULIET Ti	2018-06-29
HTR Alpes CN [SPINEART SA]	SCARLET AL-T	2018-06-21
GEG Alpes CN [SPINEART SA]	SCARLET AL-T	2018-06-21
FZX Alpes CN [SPINEART SA]	SCARLET AL-T	2018-06-21
HWT Alpes CN [SPINEART SA]	Romeo 2	2018-06-05
HWT Alpes CN [SPINEART SA]	Romeo 2 MIS	2018-06-05
HWT Alpes CN [SPINEART SA]	Perla	2018-06-05
HTW Alpes CN [SPINEART SA]	ROMEO	2018-05-30
HTO Alpes CN [SPINEART SA]	ROMEO	2018-05-30
HTX Alpes CN [SPINEART SA]	Juliet LL	2018-04-19
FZS Alpes CN [SPINEART SA]	Perla	2018-03-15
HXX Alpes CN [SPINEART SA]	Romeo 2	2018-03-06
PMN K171797 | KWQ Alpes CN [SPINEART SA]	TRYPTIK2 C-Plate	2018-02-27
HXI Alpes CN [SPINEART SA]	ROMEO	2018-01-26
PMN K173702 | MAX Alpes CN [SPINEART SA]	JULIET	2018-01-05
HWJ Alpes CN [SPINEART SA]	Romeo 2 MIS	2017-12-06
GEN Alpes CN [SPINEART SA]	ROMEO2	2017-11-20
FSM Alpes CN [SPINEART SA]	Romeo 2	2017-10-27
PMN K172065 | OVE Alpes CN [SPINEART SA]	SCARLET	2017-10-06
PMN K172065 | ODP Alpes CN [SPINEART SA]	SCARLET	2017-10-06
PMN K172101 | NKB Alpes CN [SPINEART SA]	ROMEO	2017-09-27
PMN K172101 | KWP Alpes CN [SPINEART SA]	ROMEO	2017-09-27
PMN K161888 | MAX Alpes CN [SPINEART SA]	JULIET LL	2016-09-13
PMN K153621 | MAX Alpes CN [SPINEART SA]	JULIET Ti	2016-08-09
PMN K062260 | FMF Alpes CN [SPINEART SA]	Osteoboost	2016-06-10
PMN K153042 | KWQ Alpes CN [SPINEART SA]	TRYPTIK2 C-plate	2016-05-03
PMN K153386 | NKG Alpes CN [SPINEART SA]	PERLA	2016-01-27
PMN K153386 | KWP Alpes CN [SPINEART SA]	PERLA	2016-01-27
PMN K151104 | GAD Alpes CN [SPINEART SA]	OTELO	2016-01-27
PMN K151695 | MNI Alpes CN [SPINEART SA]	ROMEO2	2015-10-08
PMN K151695 | MNH Alpes CN [SPINEART SA]	ROMEO2	2015-10-08
PMN K143214 | OVE Alpes CN [SPINEART SA]	SCARLET AC-T Lordotic version	2015-02-24
PMN K141135 | MAX Alpes CN [SPINEART SA]	JULIET LL-T	2014-12-02
PMN K142277 | MAX Alpes CN [SPINEART SA]	JULIET PO	2014-10-15
PMN K141314 | OVE Alpes CN [SPINEART SA]	SCARLET AC-T	2014-10-06
PMN K141835 | MNI Alpes CN [SPINEART SA]	ROMEO 2	2014-09-11
PMN K141835 | MNH Alpes CN [SPINEART SA]	ROMEO 2	2014-09-11
PMN K141508 | PEK Alpes CN [SPINEART SA]	ROMEO2PAD	2014-08-26
PMN K140948 | MNI Alpes CN [SPINEART SA]	ROMEO	2014-05-23
PMN K140948 | MNH Alpes CN [SPINEART SA]	ROMEO	2014-05-23
PMN K140474 | MAX Alpes CN [SPINEART SA]	JULIET ol	2014-05-06
PMN K133557 | MAX Alpes CN [SPINEART SA]	JULIET LL lateral Lumbar Cage	2014-02-14
GAD Alpes CN [SPINEART SA]	OTELO retractor	2013-12-20
PMN K041616 | MQV Alpes CN [SPINEART SA]	BGran	2013-09-16
PMN K130267 | MNI Alpes CN [SPINEART SA]	ROMEO	2013-06-06
PMN K130267 | MNH Alpes CN [SPINEART SA]	ROMEO	2013-06-06
PMN K130267 | KWP Alpes CN [SPINEART SA]	ROMEO	2013-06-06
LXH Alpes CN [SPINEART SA]	Manual surgical instrument (all ranges)	2012-11-23
HXE Alpes CN [SPINEART SA]	Fork (all ranges)	2012-11-23
HWX Alpes CN [SPINEART SA]	Bone taps ROMEO2 (multiple)	2012-11-23
HWN Alpes CN [SPINEART SA]	Compression distraction forceps (multiple all ranges)	2012-11-23
HWA Alpes CN [SPINEART SA]	Impactor pusher ( all ranges)	2012-11-23
PMN K122366 | ODP Alpes CN [SPINEART SA]	TRYPTIK	2012-10-22
PMN K112108 | MNI Alpes CN [SPINEART SA]	ROMEO LC	2011-08-30
PMN K112108 | MNH Alpes CN [SPINEART SA]	ROMEO LC	2011-08-30
PMN K112108 | KWP Alpes CN [SPINEART SA]	ROMEO LC	2011-08-30
PMN K111127 | MNI Alpes CN [SPINEART SA]	ROMEO MIS ROMEO LC	2011-08-16
PMN K111127 | MNH Alpes CN [SPINEART SA]	ROMEO MIS ROMEO LC	2011-08-16
PMN K111127 | KWP Alpes CN [SPINEART SA]	ROMEO MIS ROMEO LC	2011-08-16
PMN K101720 | MAX Alpes CN [SPINEART SA]	JULIET	2010-08-02
PMN K101678 | MNI Alpes CN [SPINEART SA]	ROMEO	2010-08-02
PMN K101678 | MNH Alpes CN [SPINEART SA]	ROMEO	2010-08-02
PMN K101678 | KWP Alpes CN [SPINEART SA]	ROMEO	2010-08-02
PMN K093936 | MNI Alpes CN [SPINEART SA]	ROMEO	2010-03-23
PMN K093936 | MNH Alpes CN [SPINEART SA]	ROMEO	2010-03-23
PMN K093936 | KWP Alpes CN [SPINEART SA]	ROMEO	2010-03-23
PMN K093170 | MNI Alpes CN [SPINEART SA]	ROMEO	2009-11-10
PMN K093170 | MNH Alpes CN [SPINEART SA]	ROMEO	2009-11-10
PMN K093170 | KWP Alpes CN [SPINEART SA]	ROMEO	2009-11-10
PMN K091873 | ODP Alpes CN [SPINEART SA]	TRYPTIK CA	2009-11-10
PMN K081888 | MAX Alpes CN [SPINEART SA]	JULIET	2009-03-24
PMN K081165 | MNI Alpes CN [SPINEART SA]	ROMEO	2009-03-24
PMN K081165 | MNH Alpes CN [SPINEART SA]	ROMEO	2009-03-24
PMN K081165 | KWP Alpes CN [SPINEART SA]	ROMEO	2009-03-24