Company · CH
Spineart
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
58510(k) clearances (5 in 12 months)
13recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 13 |
| NKB | Thoracolumbosacral Pedicle Screw System | 11 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 9 |
| OLO | Orthopedic Stereotaxic Instrument | 7 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 6 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 5 |
| MNI | Orthosis, Spinal Pedicle Fixation | 5 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 5 |
| NKG | Posterior Cervical Screw System | 3 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 3 |
| GAD | Retractor | 1 |
| PEK | Spinous Process Plate | 1 |
| PML | Bone Cement, Posterior Screw Augmentation | 1 |
| QLQ | Manual Instruments Designed For Use With Total Disc Replacement Devices | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 20, 2026 | K261049 | SCALA® TL Spineart SA, CH | MAX |
| Aug 14, 2026 | K262639 | BAGUERA® C Cervical Disc Surgical Instruments Spineart SA, CH | QLQ |
| Jul 29, 2026 | K261205 | SPINEART Navigation Instrument System Spineart SA, CH | OLO |
| May 1, 2026 | K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System Spineart SA, CH | NKB |
| Apr 9, 2026 | K254158 | SPINEART Navigation Instrument System Spineart SA, CH | OLO |
| Jun 18, 2025 | K242933 | SPINEART Navigation Instrument System Spineart SA, CH | OLO |
| Mar 7, 2025 | K242890 | SPINEART Navigation Instrument System Spineart SA, CH | OLO |
| Oct 23, 2024 | K242589 | Scarlet® AL-T Spineart SA, CH | MAX |
| Aug 7, 2024 | K241644 | SPINEART Navigation Instrument System Spineart SA, CH | OLO |
| Jul 18, 2024 | K241321 | Juliet® Ti LL Lumbar Interbody Device Spineart SA, CH | OVD |
| May 10, 2024 | K240699 | SCARLET® AC-Ti Spineart SA, CH | OVE |
| Oct 25, 2023 | K231069 | PERLA® TL Posterior Thoraco-lumbar Fixation System Spineart SA, CH | NKB |
| Jun 23, 2023 | K230774 | PERLA® TL System; TEKTONA® HV US Bone Cement Spineart, CH | PML |
| Mar 22, 2023 | K230583 | Tryptik Ti Spineart SA, CH | ODP |
| Jan 21, 2022 | K213470 | PERLA® TL Posterior Osteosynthesis System Spineart, CH | NKB |
| Mar 19, 2021 | K210472 | SPINEART Navigation Instrument System Spineart, CH | OLO |
| Jan 15, 2021 | K203506 | PERLA® TL posterior osteosynthesis system Spineart, CH | NKB |
| Dec 17, 2020 | K203222 | PERLA TL Posterior Osteosynthesis System Spineart, CH | NKB |
| May 1, 2020 | K200571 | PERLA® Posterior Occipito-Cervico-Thoracic Fixation System Spineart, CH | NKG |
| Apr 6, 2020 | K200312 | Tryptik Ti Spineart, CH | ODP |
| Feb 5, 2020 | K193396 | PERLA® TL posterior osteosynthesis system Spineart, CH | NKB |
| Jan 22, 2020 | K192993 | SCARLET AL-T Spineart, CH | OVD |
| Jun 10, 2019 | K183630 | SPINEART Navigation Instrument System Spineart SA, CH | OLO |
| May 29, 2019 | K190877 | Juliet® Ti LL Lumbar Interbody Device Spineart, CH | OVD |
| Mar 4, 2019 | K190322 | SCARLET® AC-T Secured Anterior Cervical Cage Spineart, CH | ODP |
| Feb 25, 2019 | K190071 | Perla® Posterior Cervico-Thoracic Fixation System Spineart, CH | NKG |
| Oct 9, 2018 | K181818 | Scarlet AL-T Spineart, CH | OVD |
| Jun 28, 2018 | K181203 | Juliet Ti Spineart, CH | MAX |
| Feb 26, 2018 | K171797 | TRYPTIK2 C-Plate Anterior Cervical Plate System Spineart, CH | KWQ |
| Jan 3, 2018 | K173702 | Juliet Ti LL Spineart, CH | MAX |
| Sep 29, 2017 | K172065 | SCARLET AC-T Spineart, CH | ODP |
| Sep 26, 2017 | K172101 | ROMEO® 2 Posterior Osteosynthesis System Spineart, CH | NKB |
| Sep 12, 2016 | K161888 | JULIET® LL Lateral Lumbar Cage Spineart, CH | MAX |
| Jul 15, 2016 | K153621 | Juliet® Ti Spineart, CH | MAX |
| Mar 28, 2016 | K153042 | TRYPTIK2C-plate Anterior Cervical Plate System Spineart, CH | KWQ |
| Jan 25, 2016 | K153386 | Perla Posterior Cervico-Thoracic Fixation system Spineart, CH | NKG |
| Jan 6, 2016 | K151104 | OTELO LL Spineart, CH | GAD |
| Sep 10, 2015 | K151695 | Romeo posterior osteosynthesis system Spineart, CH | MNH |
| Feb 23, 2015 | K143214 | SCARLET® AC-T Secured Anterior Cervical Cage Spineart, CH | OVE |
| Dec 1, 2014 | K141135 | JULIET LL Spineart, CH | MAX |
| Oct 14, 2014 | K142277 | JULIET PO Spineart, CH | MAX |
| Sep 29, 2014 | K141314 | SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION Spineart, CH | OVE |
| Sep 10, 2014 | K141835 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS Spineart, CH | MNI |
| Aug 21, 2014 | K141508 | ROMEO 2 PAD POSTERIOR AXIAL DEVICE Spineart, CH | PEK |
| May 20, 2014 | K140948 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart, CH | MNH |
| Apr 18, 2014 | K140474 | JULIET OL Spineart, CH | MAX |
| Feb 3, 2014 | K133557 | JULIET LL LATERAL LUMBAR CAGE Spineart, CH | MAX |
| May 31, 2013 | K130267 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart, CH | MNH |
| Oct 4, 2012 | K122366 | TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE Spineart, CH | ODP |
| Aug 19, 2011 | K112108 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart, CH | MNI |
Newest 50 of 58.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2025 | SPINEART SA Brand Name: PERLA TL MIS
Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW
Model/Catalog Number: MPF-PS 55 45-S
Software Version: Not Applicable
Product Description: CANNULATED FENESTRATED POLYAXI Open, Classified |
NKB | K203506 |
| Aug 8, 2025 | SPINEART SA 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 POLYAXI Open, Classified |
NKB | K203506 |
| May 3, 2024 | SPINEART SA 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 Open, Classified |
NKB | K193396 |
| Apr 24, 2023 | SPINEART SA 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 0 Open, Classified |
OVD | K190877 |
| Apr 9, 2021 | SPINEART SA 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 Con Terminated |
NKB | K193396 |
| Nov 22, 2019 | SPINEART SA Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures Terminated |
MAX | K153621 |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | K153042 |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | K153042 |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | K153042 |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizati Terminated |
KWQ | K153042 |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | K153042 |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | K153042 |
| Nov 27, 2017 | SPINEART SA 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 stabilizatio Terminated |
KWQ | K153042 |