Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3037407500

FEI Number

3037407500

Entity Name

ALPES CN SAS

City/State/Country

Reignier-Esery Haute-Savoie, FR

Establishment Address

356 Rue de la Tour, Reignier-Esery Haute-Savoie 74930, FR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

SPINEART SA (Owner Number: 10028947)

Owner / Operator Contact Address

Chemin du Pre-Fleuri 3, Plan-les-Ouates, CH-GE 1228, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CRIMPER, PIN (all ranges) CURE ACP 2 Talos-C (HA) Hyperlordotic ROMEO2 ROMEO MIS ROMEO LC PERLA Cure LP (IVIEW and QMAX) JULIET PO Guide, surgical, instrument (all ranges) Perla TL Romeo 2 MIS Tryptik Ti Manual surgical instrument (all ranges) FORCEPS, GENERAL & PLASTIC SURGERY (all ranges) JULIET Ti Perla TL MIS NAV Perla TL NAV INSTRUMENT, MANUAL, SURGICAL, GENERAL USE (all ranges) INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT (all ranges) GAUGE, DEPTH (all ranges) Compression distraction forceps (multiple all ranges) PROBE (all ranges) TRYPTIK CA PASSER, WIRE, ORTHOPEDIC (all ranges) OTELO Talos C HA PERLA ROMEO 2 SCARLET AC-Ti ROMEO2PAD SCARLET AC-T Talos Lumbar Perla Cure Lumbar Plate System BIT, DRILL (all ranges) DRIVER, PROSTHESIS (all ranges) Perla TL Talos®-C SCREWDRIVER (all ranges) PERLA NAV PERLA TL NAV ROMEO Cure OPEL-L JULIET LL Ti Impactor pusher ( all ranges) ROMEO TEMPLATE (all ranges) ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY (all ranges) BENDER (all ranges) TRYPTIK Scarlet AL-T Perla TL MIS Perla TL PERLA TL JULIET Ti DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY (all ranges) PERLA TL ROMEO TRYPTIK2 C-Plate Tray, surgical, instrument (all ranges) JULIET SCARLET AL-T Romeo navigation RONGEUR (all ranges) ROMEO Cure OPEL-C JULIET Ti LL Posterior Disc Prep ROMEO PERLA TL NAV TRYPTIK2 C-plate Perla TL MIS JULIET LL SCARLET AC-T Perla TL ROMEO LC REAMER (all ranges)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXQ	Crimper, Pin	Orthopedic	Class 1	888.4540	2018-08-01
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-10-26
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-10-26
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-10-08
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-10-08
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2011-08-16
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2011-08-16
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2011-08-16
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2016-01-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-01-27
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-10-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-10-15
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-06-21
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2023-06-26
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-06-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-06-26
HWJ	Awl	Orthopedic	Class 1	888.4540	2017-12-06
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-03-31
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-11-23
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-11-20
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-06-29
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-03-22
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2018-07-27
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2018-07-23
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2018-08-01
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2012-11-23
HXB	Probe	Orthopedic	Class 1	888.4540	2018-10-10
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2009-11-10
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2018-01-26
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2016-01-27
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-10-26
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2019-02-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-02-27
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-09-11
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-09-11
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2024-05-13
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2024-05-13
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2014-08-26
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2014-10-06
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-10-26
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2020-05-05
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2020-05-05
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-10-26
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2018-05-30
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2019-06-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2020-12-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-12-18
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-10-26
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2018-03-06
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-08-08
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2009-03-24
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2009-03-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2009-03-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-10-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-06-02
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2019-06-02
HWA	Impactor	Orthopedic	Class 1	888.4540	2012-11-23
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-06-06
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-06-06
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-06-06
HWT	Template	Orthopedic	Class 1	888.4800	2018-06-05
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-06-21
HXW	Bender	Orthopedic	Class 1	888.4540	2018-08-01
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2012-10-22
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2018-10-10
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-10-10
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2021-01-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-01-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2020-02-06
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2020-02-06
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-02-06
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2020-02-06
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2020-02-06
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2020-02-06
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-06-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-08-09
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-07-27
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-03-10
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2009-11-10
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2009-11-10
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2009-11-10
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2018-02-27
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-10-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2010-08-02
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-10-24
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-10-24
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-06-12
HTX	Rongeur	Orthopedic	Class 1	888.4540	2018-04-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2010-03-23
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2010-03-23
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2010-03-23
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-10-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-07-29
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-07-29
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2025-05-01
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-09-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-09-27
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-04-13
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-05-03
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-01-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-01-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-09-13
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2019-03-06
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2019-03-06
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-10-30
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-10-30
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-10-30
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-10-30
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2023-10-30
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2011-08-30
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2011-08-30
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2011-08-30
HTO	Reamer	Orthopedic	Class 1	888.4540	2018-05-30

Official Correspondent

Max LOK

US Agent Details

Emanuele Nocco Email: enocco@spineart.com Phone: (949) 3136400

Related Public Records

Same Entity

SPINEART SA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007728266	SPINEART SA	Plan-les-Ouates Geneve, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03
K062643	Life Spine	KINETIC ANTERIOR CERVICAL PLATE	2006-11-16
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037407500. Last updated year: 2026. Please use registration number 3037407500 when referencing this establishment in official correspondence.