Spineart
Medical device manufacturer in Plan-Les-Ouates, CH.
58510(k) clearances
0PMA approvals
13recalls
Device types
- MAX Intervertebral Fusion Device With Bone… 12
- NKB Thoracolumbosacral Pedicle Screw System 7
- OLO Orthopedic Stereotaxic Instrument 7
- ODP Intervertebral Fusion Device With Bone… 6
- MNH Orthosis, Spondylolisthesis Spinal Fixation 5
- MNI Orthosis, Spinal Pedicle Fixation 5
- OVD Intervertebral Fusion Device With… 4
- OVE Intervertebral Fusion Device With… 3
- NKG Posterior Cervical Screw System 3
- KWQ Appliance, Fixation, Spinal Intervertebral… 2
- PEK Spinous Process Plate 1
- GAD Retractor 1
- PML Bone Cement, Posterior Screw Augmentation 1
- QLQ Manual Instruments Designed For Use With… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261049 | Scala® TLMAX · Traditional | 08/20/2026SE |
| K262639 | BAGUERA® C Cervical Disc Surgical InstrumentsQLQ · Traditional | 08/14/2026SE |
| K261205 | SPINEART Navigation Instrument SystemOLO · Traditional | 07/29/2026SE |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation SystemNKB · Traditional | 05/01/2026SE |
| K254158 | SPINEART Navigation Instrument SystemOLO · Special | 04/09/2026SE |
| K242933 | SPINEART Navigation Instrument SystemOLO · Traditional | 06/18/2025SE |
| K242890 | SPINEART Navigation Instrument SystemOLO · Traditional | 03/07/2025SE |
| K242589 | Scarlet® AL-TMAX · Traditional | 10/23/2024SE |
| K241644 | SPINEART Navigation Instrument SystemOLO · Special | 08/07/2024SE |
| K241321 | Juliet® Ti LL Lumbar Interbody DeviceOVD · Traditional | 07/18/2024SE |
| K240699 | SCARLET® AC-TiOVE · Traditional | 05/10/2024SE |
| K231069 | PERLA® TL Posterior Thoraco-lumbar Fixation SystemNKB · Traditional | 10/25/2023SE |
| K230774 | PERLA® TL System; TEKTONA® HV US Bone CementPML · Traditional | 06/23/2023SE |
| K230583 | Tryptik TiODP · Special | 03/22/2023SE |
| K213470 | PERLA® TL Posterior Osteosynthesis SystemNKB · Traditional | 01/21/2022SE |
| K210472 | SPINEART Navigation Instrument SystemOLO · Special | 03/19/2021SE |
| K203506 | PERLA® TL posterior osteosynthesis systemNKB · Traditional | 01/15/2021SE |
| K203222 | PERLA TL Posterior Osteosynthesis SystemNKB · Traditional | 12/17/2020SE |
| K200571 | PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemNKG · Traditional | 05/01/2020SE |
| K200312 | Tryptik TiODP · Traditional | 04/06/2020SE |
| K193396 | PERLA® TL posterior osteosynthesis systemNKB · Traditional | 02/05/2020SE |
| K192993 | Scarlet Al-TOVD · Traditional | 01/22/2020SE |
| K183630 | SPINEART Navigation Instrument SystemOLO · Traditional | 06/10/2019SE |
| K190877 | Juliet® Ti LL Lumbar Interbody DeviceOVD · Traditional | 05/29/2019SE |
| K190322 | SCARLET® AC-T Secured Anterior Cervical CageODP · Special | 03/04/2019SE |
| K190071 | Perla® Posterior Cervico-Thoracic Fixation SystemNKG · Special | 02/25/2019SE |
| K181818 | Scarlet AL-TOVD · Traditional | 10/09/2018SE |
| K181203 | Juliet TiMAX · Special | 06/28/2018SE |
| K171797 | TRYPTIK2 C-Plate Anterior Cervical Plate SystemKWQ · Traditional | 02/26/2018SE |
| K173702 | Juliet Ti LLMAX · Special | 01/03/2018SE |
| K172065 | Scarlet Ac-TODP · Traditional | 09/29/2017SE |
| K172101 | ROMEO® 2 Posterior Osteosynthesis SystemNKB · Traditional | 09/26/2017SE |
| K161888 | JULIET® LL Lateral Lumbar CageMAX · Special | 09/12/2016SE |
| K153621 | Juliet® TiMAX · Traditional | 07/15/2016SE |
| K153042 | TRYPTIK2C-plate Anterior Cervical Plate SystemKWQ · Traditional | 03/28/2016SE |
| K153386 | Perla Posterior Cervico-Thoracic Fixation systemNKG · Traditional | 01/25/2016SE |
| K151104 | Otelo LLGAD · Traditional | 01/06/2016SE |
| K151695 | Romeo posterior osteosynthesis systemMNH · Traditional | 09/10/2015SE |
| K143214 | SCARLET® AC-T Secured Anterior Cervical CageOVE · Traditional | 02/23/2015SE |
| K141135 | Juliet LLMAX · Traditional | 12/01/2014SE |
| K142277 | Juliet PoMAX · Traditional | 10/14/2014SE |
| K141314 | Scarlet Ac-T Secured Anterior Cervical Cage and Associated InstrumentationOVE · Traditional | 09/29/2014SE |
| K141835 | Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent RodsMNI · Special | 09/10/2014SE |
| K141508 | Romeo 2 Pad Posterior Axial DevicePEK · Traditional | 08/21/2014SE |
| K140948 | Romeo Posterior Osteosynthesis SystemMNH · Special | 05/20/2014SE |
| K140474 | Juliet OlMAX · Traditional | 04/18/2014SE |
| K133557 | Juliet LL Lateral Lumbar CageMAX · Traditional | 02/03/2014SE |
| K130267 | Romeo Posterior Osteosynthesis SystemMNH · Traditional | 05/31/2013SE |
| K122366 | Tryptik CC Anterior Intersomatic Cervical CageODP · Special | 10/04/2012SE |
| K112108 | Romeo Posterior Osteosynthesis SystemMNI · Special | 08/19/2011SE |
| K111127 | Romeo Posterior Osteosynthesis SystemMNI · Special | 08/11/2011SE |
| K101678 | Romeo Posterior Osteosynthesis SystemMNH · Special | 07/28/2010SE |
| K101720 | Juliet OlMAX · Special | 07/16/2010SE |
| K093936 | Romeo Posterior Osteosynthesis SystemMNI · Special | 03/11/2010SE |
| K093170 | Romeo Posterior Osteosynthesis SystemMNI · Special | 11/04/2009SE |
| K091873 | Tryptik Ca Anterior Intersomatic Cervical Cage, Models Mos-Ca 12 05-S, Mos-Ca 12 O6-SODP · Abbreviated | 09/18/2009SE |
| K081888 | Dynamik Intervertebral Body Fusion DeviceMAX · Traditional | 02/06/2009SE |
| K081165 | Ellipse Lumbar Posterior Osteosynthesis SystemMNH · Traditional | 12/17/2008SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2280-2025 Class II | Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW…Cannulated fenestrated polyaxial screws may be incorrectly labeled | 06/30/2025Open, Classified |
| Z-2279-2025 Class II | Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW…Cannulated fenestrated polyaxial screws may be incorrectly labeled | 06/30/2025Open, Classified |
| Z-1758-2024 Class II | 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…Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head.… | 03/15/2024Open, Classified |
| Z-1426-2023 Class II | JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S…JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble… | 03/16/2023Open, Classified |
| Z-1975-2021 Class II | PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft…Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size. | 04/09/2021Terminated |
| Z-0546-2020 Class III | Intersomatic JULIET Ti OL cage. For use in orthopedic spinal proceduresInner blister pack label is incorrect and does not match the correct external box label. | 02/05/2019Terminated |
| Z-0342-2018 Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45…Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the… | 11/27/2017Terminated |
| Z-0341-2018 Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45…Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the… | 11/27/2017Terminated |
| Z-0340-2018 Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45…Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the… | 11/27/2017Terminated |
| Z-0339-2018 Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45…Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the… | 11/27/2017Terminated |
| Z-0338-2018 Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40…Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the… | 11/27/2017Terminated |
| Z-0337-2018 Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40…Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the… | 11/27/2017Terminated |
| Z-0336-2018 Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40…Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the… | 11/27/2017Terminated |