Data / Medical devices / Switzerland / Spineart SA

Spineart SA: FDA-registered device maker in Plan-les-Ouates, Switzerland, 70 510(k) clearances and 1 PMA approval

Name: Spineart SA FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Spineart SA is registered with the FDA (registration 3007728266) in Plan-les-Ouates, Switzerland. It lists 49 device types. The FDA files 70 510(k) clearances and 1 PMA approval under its listings, the newest dated August 20, 2026. 6 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3007728266
Address: Chemin du Pre-Fleuri 3, Plan-les-Ouates, Switzerland, 1228
Owner or operator: SPINEART SA (10028947)
Roles: Complaint file establishment, Specification developer
First device listed: March 24, 2009
Registered through: 2027
Brand names listed: BAGUERA C, BENDER (all ranges), BIT, DRILL (all ranges), Bone taps ROMEO2 (multiple), CRIMPER, PIN (all ranges), CURE ACP 2, CURETTE, SURGICAL, GENERAL USE (all ranges), CURE ACP and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Awl	HWJ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Bender	HXW	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Bit, Drill	HTW	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Bone Cement, Posterior Screw Augmentation	PML	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Crimper, Pin	HXQ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Curette, Surgical, General Use	FZS	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Dispenser, Cement	KIH	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Driver, Prosthesis	HWR	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Extractor	HWB	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Fork	HXE	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Impactor	HWA	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Instrument, Compression	HWN	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Manual Instruments Designed For Use With Total Disc Replacement Devices	QLQ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Osteotome	HWM	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Passer, Wire, Orthopedic	HXI	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Posterior Cervical Screw System	NKG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Probe	HXB	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Intervertebral Disc	MJO	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Rasp	HTR	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Razor, Surgical	LWK	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Reamer	HTO	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Retractor	GAD	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Rongeur	HTX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Screwdriver	HXX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Spinous Process Plate	PEK	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Tap, Bone	HWX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Template	HWT	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Wrench	HXC	1	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 20, 2026	K261049	SCALA® TL	MAX	Substantially Equivalent	Spineart SA	accessdata.fda.gov
August 14, 2026	K262639	BAGUERA® C Cervical Disc Surgical Instruments	QLQ	Substantially Equivalent	Spineart SA	accessdata.fda.gov
July 29, 2026	K261205	SPINEART Navigation Instrument System	OLO	Substantially Equivalent	Spineart SA	accessdata.fda.gov
May 1, 2026	K253966	PERLA® TL Posterior Thoraco-lumbar Fixation System	NKB	Substantially Equivalent	Spineart SA	accessdata.fda.gov
April 9, 2026	K254158	SPINEART Navigation Instrument System	OLO	Substantially Equivalent	Spineart SA	accessdata.fda.gov
June 18, 2025	K242933	SPINEART Navigation Instrument System	OLO	Substantially Equivalent	Spineart SA	accessdata.fda.gov
March 7, 2025	K242890	SPINEART Navigation Instrument System	OLO	Substantially Equivalent	Spineart SA	accessdata.fda.gov
October 23, 2024	K242589	Scarlet® AL-T	MAX	Substantially Equivalent	Spineart SA	accessdata.fda.gov
August 7, 2024	K241644	SPINEART Navigation Instrument System	OLO	Substantially Equivalent	Spineart SA	accessdata.fda.gov
July 18, 2024	K241321	Juliet® Ti LL Lumbar Interbody Device	OVD	Substantially Equivalent	Spineart SA	accessdata.fda.gov
May 10, 2024	K240699	SCARLET® AC-Ti	OVE	Substantially Equivalent	Spineart SA	accessdata.fda.gov
October 25, 2023	K231069	PERLA® TL Posterior Thoraco-lumbar Fixation System	NKB	Substantially Equivalent	Spineart SA	accessdata.fda.gov
June 23, 2023	K230774	PERLA® TL System; TEKTONA® HV US Bone Cement	PML	Substantially Equivalent	Spineart	accessdata.fda.gov
March 22, 2023	K230583	Tryptik Ti	ODP	Substantially Equivalent	Spineart SA	accessdata.fda.gov
January 21, 2022	K213470	PERLA® TL Posterior Osteosynthesis System	NKB	Substantially Equivalent	Spineart	accessdata.fda.gov
March 19, 2021	K210472	SPINEART Navigation Instrument System	OLO	Substantially Equivalent	Spineart	accessdata.fda.gov
March 18, 2021	K210286	Cure 2.0 Anterior Cervical Plate (ACP) System	KWQ	Substantially Equivalent	Meditech Spine, LLC	accessdata.fda.gov
January 15, 2021	K203506	PERLA® TL posterior osteosynthesis system	NKB	Substantially Equivalent	Spineart	accessdata.fda.gov
December 17, 2020	K203222	PERLA TL Posterior Osteosynthesis System	NKB	Substantially Equivalent	Spineart	accessdata.fda.gov
September 11, 2020	K201506	Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System	ODP	Substantially Equivalent	Meditech Spine, LLC	accessdata.fda.gov
May 12, 2020	K201136	Cure Lumbar Plate System	KWQ	Substantially Equivalent	Meditech Spine, LLC	accessdata.fda.gov
May 1, 2020	K200571	PERLA® Posterior Occipito-Cervico-Thoracic Fixation System	NKG	Substantially Equivalent	Spineart	accessdata.fda.gov
April 6, 2020	K200312	Tryptik Ti	ODP	Substantially Equivalent	Spineart	accessdata.fda.gov
February 5, 2020	K193396	PERLA® TL posterior osteosynthesis system	NKB	Substantially Equivalent	Spineart	accessdata.fda.gov
January 22, 2020	K192993	SCARLET AL-T	OVD	Substantially Equivalent	Spineart	accessdata.fda.gov
June 10, 2019	K183630	SPINEART Navigation Instrument System	OLO	Substantially Equivalent	Spineart SA	accessdata.fda.gov
May 29, 2019	K190877	Juliet® Ti LL Lumbar Interbody Device	OVD	Substantially Equivalent	Spineart	accessdata.fda.gov
March 4, 2019	K190322	SCARLET® AC-T Secured Anterior Cervical Cage	ODP	Substantially Equivalent	Spineart	accessdata.fda.gov
February 25, 2019	K190071	Perla® Posterior Cervico-Thoracic Fixation System	NKG	Substantially Equivalent	Spineart	accessdata.fda.gov
October 9, 2018	K181818	Scarlet AL-T	OVD	Substantially Equivalent	Spineart	accessdata.fda.gov
August 31, 2018	K181543	Cure OPEL-C Plate System	KWQ	Substantially Equivalent	Meditech Spine, LLC	accessdata.fda.gov
June 28, 2018	K181203	Juliet Ti	MAX	Substantially Equivalent	Spineart	accessdata.fda.gov
April 23, 2018	K180090	Cure Lumbar Plate System	KWQ	Substantially Equivalent	Meditech Spine, LLC	accessdata.fda.gov
February 26, 2018	K171797	TRYPTIK2 C-Plate Anterior Cervical Plate System	KWQ	Substantially Equivalent	Spineart	accessdata.fda.gov
January 3, 2018	K173702	Juliet Ti LL	MAX	Substantially Equivalent	Spineart	accessdata.fda.gov
September 29, 2017	K172065	SCARLET AC-T	ODP	Substantially Equivalent	Spineart	accessdata.fda.gov
September 26, 2017	K172101	ROMEO® 2 Posterior Osteosynthesis System	NKB	Substantially Equivalent	Spineart	accessdata.fda.gov
June 16, 2017	K171538	Cure Lumbar Plate System	KWQ	Substantially Equivalent	Meditech Spine, LLC	accessdata.fda.gov
June 2, 2017	K170395	Talos® Lumbar (HA) PEEK IBF Devices	MAX	Substantially Equivalent	Meditech Spine, LLC	accessdata.fda.gov
September 12, 2016	K161888	JULIET® LL Lateral Lumbar Cage	MAX	Substantially Equivalent	Spineart	accessdata.fda.gov
July 15, 2016	K153621	Juliet® Ti	MAX	Substantially Equivalent	Spineart	accessdata.fda.gov
July 1, 2016	K160604	Cure Anterior Cervical Plate (ACP) System	KWQ	Substantially Equivalent	Meditech Spine, LLC	accessdata.fda.gov
March 28, 2016	K153042	TRYPTIK2C-plate Anterior Cervical Plate System	KWQ	Substantially Equivalent	Spineart	accessdata.fda.gov
January 25, 2016	K153386	Perla Posterior Cervico-Thoracic Fixation system	NKG	Substantially Equivalent	Spineart	accessdata.fda.gov
January 6, 2016	K151104	OTELO LL	GAD	Substantially Equivalent	Spineart	accessdata.fda.gov
October 14, 2015	K150788	Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices	ODP	Substantially Equivalent	Meditech Spine, LLC	accessdata.fda.gov
September 10, 2015	K151695	Romeo posterior osteosynthesis system	MNH	Substantially Equivalent	Spineart	accessdata.fda.gov
February 23, 2015	K143214	SCARLET® AC-T Secured Anterior Cervical Cage	OVE	Substantially Equivalent	Spineart	accessdata.fda.gov
February 22, 2015	K142345	Talos-C(HA) Cervical Intervertebral Body Fusion Devices	ODP	Substantially Equivalent	Meditech Spine, LLC	accessdata.fda.gov
December 1, 2014	K141135	JULIET LL	MAX	Substantially Equivalent	Spineart	accessdata.fda.gov
October 14, 2014	K142277	JULIET PO	MAX	Substantially Equivalent	Spineart	accessdata.fda.gov
September 29, 2014	K141314	SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION	OVE	Substantially Equivalent	Spineart	accessdata.fda.gov
September 10, 2014	K141835	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS	MNI	Substantially Equivalent	Spineart	accessdata.fda.gov
August 21, 2014	K141508	ROMEO 2 PAD POSTERIOR AXIAL DEVICE	PEK	Substantially Equivalent	Spineart	accessdata.fda.gov
May 20, 2014	K140948	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM	MNH	Substantially Equivalent	Spineart	accessdata.fda.gov
April 18, 2014	K140474	JULIET OL	MAX	Substantially Equivalent	Spineart	accessdata.fda.gov
February 3, 2014	K133557	JULIET LL LATERAL LUMBAR CAGE	MAX	Substantially Equivalent	Spineart	accessdata.fda.gov
May 31, 2013	K130267	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM	MNH	Substantially Equivalent	Spineart	accessdata.fda.gov
March 28, 2013	K122850	TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES	ODP	Substantially Equivalent	Meditech Advisors, LLC	accessdata.fda.gov
October 4, 2012	K122366	TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE	ODP	Substantially Equivalent	Spineart	accessdata.fda.gov
August 19, 2011	K112108	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM	MNI	Substantially Equivalent	Spineart	accessdata.fda.gov
August 11, 2011	K111127	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM	MNI	Substantially Equivalent	Spineart	accessdata.fda.gov
July 28, 2010	K101678	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM	MNH	Substantially Equivalent	Spineart	accessdata.fda.gov
July 16, 2010	K101720	JULIET OL	MAX	Substantially Equivalent	Spineart	accessdata.fda.gov
March 11, 2010	K093936	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM	MNI	Substantially Equivalent	Spineart	accessdata.fda.gov
November 4, 2009	K093170	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM	MNI	Substantially Equivalent	Spineart	accessdata.fda.gov
September 18, 2009	K091873	TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S	ODP	Substantially Equivalent	Spineart	accessdata.fda.gov
July 15, 2009	K090707	TALOS INTERVERTEBRAL BODY FUSION DEVICE	MAX	Substantially Equivalent	Meditech Advisors, LLC	accessdata.fda.gov
February 6, 2009	K081888	DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE	MAX	Substantially Equivalent	Spineart	accessdata.fda.gov
December 17, 2008	K081165	ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM	MNH	Substantially Equivalent	Spineart	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
August 10, 2026	P250042	BAGUERA®C Cervical Disc Prosthesis	MJO	2	September 22, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 30, 2025	97248	Class II	Ongoing	Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: N	Cannulated fenestrated polyaxial screws may be incorrectly labeled	accessdata.fda.gov
March 15, 2024	94257	Class II	Ongoing	PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S TLF-DS 65 50-S T	Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The setscrew is tightened to torque but position askew	accessdata.fda.gov
March 16, 2023	91973	Class II	Ongoing	JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S; JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S	JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the preparation stage before implantation, or during surgery when removing the implant holder, which could cause surgical delay.	accessdata.fda.gov
April 9, 2021	87971	Class II	Terminated	PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PER	Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.	accessdata.fda.gov
February 5, 2019	84219	Class III	Terminated	Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures	Inner blister pack label is incorrect and does not match the correct external box label.	accessdata.fda.gov
November 27, 2017	78640	Class II	Terminated	TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spin	Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.	accessdata.fda.gov

Compare with other makers

Updated September 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.