ALPES CN SAS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3037407500 | 3037407500 | ALPES CN SAS | 1 | N | 2026-01-01 | 356 Rue de la Tour Reignier-Esery Haute-Savoie FR 74930 |
| 3010658151 | 3010658151 | Alpes CN | 1 | N | 2020-04-25 | Immeuble ABC3, 80 rue Douglas Engelbart, Archamps Technopole, Archamps Haute-Savoie FR 74160 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 338209 | 1609280784 | K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | NKB | 2026-05-01 |
| 230444 | 1013450679 | K200312 | Tryptik Ti | ODP | 2020-04-06 |
| 230444 | 1001378293 | K193396 | PERLA® TL posterior osteosynthesis system | NKB | 2020-02-05 |
| 230444 | 1564169452 | K192993 | SCARLET AL-T | OVD | 2020-01-22 |
| 230444 | 1119113105 | K190877 | Juliet® Ti LL Lumbar Interbody Device | OVD | 2019-05-29 |
| 230444 | 1372925146 | K190322 | SCARLET® AC-T Secured Anterior Cervical Cage | ODP | 2019-03-04 |
| 230444 | 1584924998 | K190071 | Perla® Posterior Cervico-Thoracic Fixation System | NKG | 2019-02-25 |
| 230444 | 1414776448 | K183630 | SPINEART Navigation Instrument System | OLO | 2019-06-10 |
| 230444 | 1203331741 | K181818 | Scarlet AL-T | OVD | 2018-10-09 |
| 230444 | 1986344638 | K181203 | Juliet Ti | MAX | 2018-06-28 |
| 230444 | 1323202594 | K173702 | Juliet Ti LL | MAX | 2018-01-03 |
| 230444 | 1176655993 | K172101 | ROMEO® 2 Posterior Osteosynthesis System | NKB | 2017-09-26 |
| 230444 | 1079078178 | K172065 | SCARLET AC-T | ODP | 2017-09-29 |
| 230444 | 1018662881 | K171797 | TRYPTIK2 C-Plate Anterior Cervical Plate System | KWQ | 2018-02-26 |
| 230444 | 1308390167 | K161888 | JULIET® LL Lateral Lumbar Cage | MAX | 2016-09-12 |
| 230444 | 1277765422 | K153621 | Juliet® Ti | MAX | 2016-07-15 |
| 230444 | 1567149570 | K153386 | Perla Posterior Cervico-Thoracic Fixation system | NKG | 2016-01-25 |
| 230444 | 1029612242 | K153042 | TRYPTIK2C-plate Anterior Cervical Plate System | KWQ | 2016-03-28 |
| 230444 | 1064250179 | K151695 | Romeo posterior osteosynthesis system | MNH | 2015-09-10 |
| 230444 | 1946523866 | K151104 | OTELO LL | GAD | 2016-01-06 |
| 338209 | 1946523866 | K151104 | OTELO LL | GAD | 2016-01-06 |
| 230444 | 1058600185 | K143214 | SCARLET® AC-T Secured Anterior Cervical Cage | OVE | 2015-02-23 |
| 230444 | 1560673526 | K142277 | JULIET PO | MAX | 2014-10-14 |
| 230444 | 1000688396 | K141835 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS | MNI | 2014-09-10 |
| 230444 | 1873689679 | K141508 | ROMEO 2 PAD POSTERIOR AXIAL DEVICE | PEK | 2014-08-21 |
| 230444 | 1269313561 | K141314 | SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION | OVE | 2014-09-29 |
| 230444 | 1680843986 | K141135 | JULIET LL | MAX | 2014-12-01 |
| 230444 | 1273922988 | K140948 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | MNH | 2014-05-20 |
| 230444 | 1069547191 | K140474 | JULIET OL | MAX | 2014-04-18 |
| 230444 | 1271332203 | K133557 | JULIET LL LATERAL LUMBAR CAGE | MAX | 2014-02-03 |
| 230444 | 1388350089 | K130267 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | MNH | 2013-05-31 |
| 230444 | 1099537080 | K122366 | TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE | ODP | 2012-10-04 |
| 230444 | 2058691286 | K112108 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | MNI | 2011-08-19 |
| 230444 | 1829517480 | K111127 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | MNI | 2011-08-11 |
| 230444 | 2001341187 | K101720 | JULIET OL | MAX | 2010-07-16 |
| 230444 | 1929217189 | K101678 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | MNH | 2010-07-28 |
| 230444 | 1450026049 | K093936 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | MNI | 2010-03-11 |
| 230444 | 1142861659 | K093170 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | MNI | 2009-11-04 |
| 230444 | 1011604971 | K091873 | TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S | ODP | 2009-09-18 |
| 230444 | 1493153197 | K081888 | DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE | MAX | 2009-02-06 |
| 230444 | 1975520684 | K081165 | ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM | MNH | 2008-12-17 |
| 230444 | 1685872668 | K062260 | OSTEOBOOST-BMA | FMF | 2006-10-26 |
| 230444 | 1975731753 | K041616 | BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID | MQV | 2004-08-25 |
| 230444 | 1009294832 | ||||
| 230444 | 1026047705 | ||||
| 230444 | 1027681143 | ||||
| 230444 | 1069776162 | ||||
| 230444 | 1076458223 | ||||
| 230444 | 1094806934 | ||||
| 230444 | 1155181290 | ||||
| 230444 | 1160320385 | ||||
| 230444 | 1308504722 | ||||
| 230444 | 1312138718 | ||||
| 230444 | 1329822189 | ||||
| 230444 | 1366086711 | ||||
| 230444 | 1370055075 | ||||
| 230444 | 1377386308 | ||||
| 230444 | 1379485701 | ||||
| 230444 | 1450784752 | ||||
| 230444 | 1489807620 | ||||
| 230444 | 1557127216 | ||||
| 230444 | 1600777918 | ||||
| 230444 | 1634391081 | ||||
| 230444 | 1649173655 | ||||
| 230444 | 1650274717 | ||||
| 230444 | 1650959693 | ||||
| 230444 | 1724905685 | ||||
| 230444 | 1758912546 | ||||
| 230444 | 1798144187 | ||||
| 230444 | 1825976399 | ||||
| 230444 | 1917692944 | ||||
| 230444 | 2058553463 | ||||
| 338209 | 1000688396 | ||||
| 338209 | 1001378293 | ||||
| 338209 | 1009294832 | ||||
| 338209 | 1011604971 | ||||
| 338209 | 1013450679 | ||||
| 338209 | 1018662881 | ||||
| 338209 | 1026047705 | ||||
| 338209 | 1027681143 | ||||
| 338209 | 1029612242 | ||||
| 338209 | 1043709887 | ||||
| 338209 | 1048595010 | ||||
| 338209 | 1048947979 | ||||
| 338209 | 1058600185 | ||||
| 338209 | 1064250179 | ||||
| 338209 | 1069547191 | ||||
| 338209 | 1069776162 | ||||
| 338209 | 1076458223 | ||||
| 338209 | 1079078178 | ||||
| 338209 | 1094806934 | ||||
| 338209 | 1099537080 | ||||
| 338209 | 1119113105 | ||||
| 338209 | 1128383042 | ||||
| 338209 | 1142861659 | ||||
| 338209 | 1155181290 | ||||
| 338209 | 1160320385 | ||||
| 338209 | 1169817055 | ||||
| 338209 | 1176655993 | ||||
| 338209 | 1203331741 | ||||
| 338209 | 1234648798 | ||||
| 338209 | 1269313561 | ||||
| 338209 | 1271332203 | ||||
| 338209 | 1273922988 | ||||
| 338209 | 1277765422 | ||||
| 338209 | 1282398515 | ||||
| 338209 | 1304324829 | ||||
| 338209 | 1308390167 | ||||
| 338209 | 1308504722 | ||||
| 338209 | 1312138718 | ||||
| 338209 | 1321565260 | ||||
| 338209 | 1323202594 | ||||
| 338209 | 1329822189 | ||||
| 338209 | 1366086711 | ||||
| 338209 | 1370055075 | ||||
| 338209 | 1372925146 | ||||
| 338209 | 1377386308 | ||||
| 338209 | 1379485701 | ||||
| 338209 | 1388350089 | ||||
| 338209 | 1414776448 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MAX | 10 | 2018-06-28 |
| ODP | 5 | 2020-04-06 |
| MNH | 5 | 2015-09-10 |
| MNI | 5 | 2014-09-10 |
| NKB | 3 | 2026-05-01 |
| OVD | 3 | 2020-01-22 |
| NKG | 2 | 2019-02-25 |
| KWQ | 2 | 2018-02-26 |
| GAD | 2 | 2016-01-06 |
| OVE | 2 | 2015-02-23 |
| OLO | 1 | 2019-06-10 |
| PEK | 1 | 2014-08-21 |
| FMF | 1 | 2006-10-26 |
| MQV | 1 | 2004-08-25 |