Spineart SA

• OLO — Neurology6 devices
• MAX — Orthopedic2 devices
• NKB — Orthopedic2 devices
• ODP — Orthopedic1 device
• OVD — Orthopedic1 device
• OVE — Orthopedic1 device
• QLQ — Orthopedic1 device

• Z-2280-2025 — 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 POLYAXIAL SCREWClass II·Ongoing·2025-06-30
• Z-2279-2025 — 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: NoClass II·Ongoing·2025-06-30
• Z-1758-2024 — 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 The PERLA¿ TL system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (painful degeneration of the disc), spondylolisthesis, trauma, spinal stenosis, deformities (i.e. scoliosis, kyphosis, or lordosis), tumor and failed previous fusion (pseudarthrosis).Class II·Ongoing·2024-03-15
• Z-1426-2023 — 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, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL 04 18-SClass II·Ongoing·2023-03-16
• Z-1975-2021 — 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 PERLA TL Lateral Connector Open, 30mmClass II·Terminated·2021-04-09
• Z-0546-2020 — Intersomatic JULIET Ti OL cage. For use in orthopedic spinal proceduresClass III·Terminated·2019-02-05
• Z-0336-2018 — 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 spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.Class II·Terminated·2017-11-27
• Z-0337-2018 — 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 stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.Class II·Terminated·2017-11-27
• Z-0340-2018 — 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 stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.Class II·Terminated·2017-11-27
• Z-0339-2018 — 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 stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.Class II·Terminated·2017-11-27

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K261049 — SCALA® TLCode MAX·2026-08-20
• K262639 — BAGUERA® C Cervical Disc Surgical InstrumentsCode QLQ·2026-08-14
• K261205 — SPINEART Navigation Instrument SystemCode OLO·2026-07-29
• K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation SystemCode NKB·2026-05-01
• K254158 — SPINEART Navigation Instrument SystemCode OLO·2026-04-09
• K242933 — SPINEART Navigation Instrument SystemCode OLO·2025-06-18
• K242890 — SPINEART Navigation Instrument SystemCode OLO·2025-03-07
• K242589 — Scarlet® AL-TCode MAX·2024-10-23
• K241644 — SPINEART Navigation Instrument SystemCode OLO·2024-08-07
• K241321 — Juliet® Ti LL Lumbar Interbody DeviceCode OVD·2024-07-18
• K240699 — SCARLET® AC-TiCode OVE·2024-05-10
• K231069 — PERLA® TL Posterior Thoraco-lumbar Fixation SystemCode NKB·2023-10-25
• K230583 — Tryptik TiCode ODP·2023-03-22
• K183630 — SPINEART Navigation Instrument SystemCode OLO·2019-06-10