Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007728266

FEI Number

3007728266

Entity Name

SPINEART SA

City/State/Country

Plan-les-Ouates Geneve, CH

Establishment Address

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

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

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

K142277

PMA Number

N/A

All Registered Proprietary Names

JULIET Cure Lumbar Plate System PASSER, WIRE, ORTHOPEDIC (all ranges) CURE ACP 2 ROMEO2PAD JULIET ol RASP (all ranges) Cure OPEL-L Manual surgical instrument (all ranges) JULIET LL-T JULIET Ti Perla TL SCARLET AC-T Tryptik Ti ROMEO SCARLET AL-T ROMEO Scarlet AL-T Guide, surgical, instrument (all ranges) OTELO retractor DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY (all ranges) BENDER (all ranges) JULIET Ti LL DRIVER, PROSTHESIS (all ranges) JULIET Ti Cure OPEL-C ROMEO 2 Bone taps ROMEO2 (multiple) Fork (all ranges) Tray, surgical, instrument (all ranges) ROMEO JULIET LL lateral Lumbar Cage INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT (all ranges) TRYPTIK2 C-Plate JULIET LL SCARLET AC-T Lordotic version Perla TL MIS TRYPTIK BAGUERA C PERLA TL NAV ROMEO MIS ROMEO LC Talos®-C TEMPLATE (all ranges) PERLA TL CURE ACP PERLA RAZOR, SURGICAL (all ranges) PROBE (all ranges) REAMER (all ranges) ROMEO Perla TL MIS TAPE, MEASURING, RULERS AND CALIPERS (all ranges) Talos Lumbar CRIMPER, PIN (all ranges) ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY (all ranges) PERLA Perla Perla TL TRYPTIK2 C-plate JULIET ROMEO Talos® Lumbar (HA) PEEK IBF Devices JULIET FORCEPS, GENERAL & PLASTIC SURGERY (all ranges) OTELO SCREWDRIVER (all ranges) PERLA NAV PERLA TL NAV ROMEO2 Talos C HA Compression distraction forceps (multiple all ranges) ROMEO LC JULIET LL Ti PERLA TL Perla TL SCARLET Perla TL MIS NAV Perla TL NAV SCARLET AC-T JULIET PO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2009-03-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-10-26
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2018-01-26
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-10-26
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2014-08-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-05-06
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2018-06-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-10-26
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-11-23
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-12-02
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-06-29
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
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
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2020-04-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2010-08-02
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2010-08-02
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	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
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
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
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-06-21
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-12-20
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-07-27
HXW	Bender	Orthopedic	Class 1	888.4540	2018-08-01
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
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2019-06-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-08-09
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-10-26
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
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2012-11-23
HXE	Fork	Orthopedic	Class 1	888.4540	2012-11-23
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-10-27
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
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-02-14
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2018-07-23
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2018-02-27
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	2015-02-24
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
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2012-10-22
HWB	Extractor	Orthopedic	Class 1	888.4540	2024-06-14
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-04-13
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
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-10-26
HWT	Template	Orthopedic	Class 1	888.4800	2018-06-05
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-06-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-10-26
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
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-07-27
HXB	Probe	Orthopedic	Class 1	888.4540	2018-10-10
HTO	Reamer	Orthopedic	Class 1	888.4540	2018-05-30
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
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
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2018-08-01
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-10-26
HXQ	Crimper, Pin	Orthopedic	Class 1	888.4540	2018-08-01
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-06-21
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
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
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2024-12-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-05-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-01-05
HXC	Wrench	Orthopedic	Class 1	888.4540	2024-01-29
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
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-10-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2010-08-02
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-11-20
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2016-01-27
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2018-03-06
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-08-08
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
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-10-26
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2012-11-23
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
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
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2026-05-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-05-04
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-05-04
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	2017-10-06
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2017-10-06
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-03-22
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	2014-10-15

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
3037407500	ALPES CN SAS	Reignier-Esery Haute-Savoie, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

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-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007728266. Last updated year: 2026. Please use registration number 3007728266 when referencing this establishment in official correspondence.