SPINEART SA

FDA Regulatory Profile

Summary

Total Recalls
13
510(k) Clearances
53
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2280-2025Class IIBrand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog NumbJune 30, 2025
Z-2279-2025Class IIBrand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog NumbJune 30, 2025
Z-1758-2024Class IIPERLA 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 45March 15, 2024
Z-1426-2023Class IIJULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-March 16, 2023
Z-1975-2021Class IIPERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograftApril 9, 2021
Z-0546-2020Class IIIIntersomatic JULIET Ti OL cage. For use in orthopedic spinal proceduresFebruary 5, 2019
Z-0339-2018Class IITRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 November 27, 2017
Z-0338-2018Class IITRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 November 27, 2017
Z-0341-2018Class IITRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 November 27, 2017
Z-0342-2018Class IITRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 November 27, 2017
Z-0336-2018Class IITRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 November 27, 2017
Z-0340-2018Class IITRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2 November 27, 2017
Z-0337-2018Class IITRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 November 27, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K242933SPINEART Navigation Instrument SystemJune 18, 2025
K242890SPINEART Navigation Instrument SystemMarch 7, 2025
K242589Scarlet® AL-TOctober 23, 2024
K241644SPINEART Navigation Instrument SystemAugust 7, 2024
K241321Juliet® Ti LL Lumbar Interbody DeviceJuly 18, 2024
K240699SCARLET® AC-TiMay 10, 2024
K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemOctober 25, 2023
K230774PERLA® TL System; TEKTONA® HV US Bone CementJune 23, 2023
K230583Tryptik TiMarch 22, 2023
K213470PERLA® TL Posterior Osteosynthesis SystemJanuary 21, 2022
K210472SPINEART Navigation Instrument SystemMarch 19, 2021
K203506PERLA® TL posterior osteosynthesis systemJanuary 15, 2021
K203222PERLA TL Posterior Osteosynthesis SystemDecember 17, 2020
K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemMay 1, 2020
K200312Tryptik TiApril 6, 2020
K193396PERLA® TL posterior osteosynthesis systemFebruary 5, 2020
K192993SCARLET AL-TJanuary 22, 2020
K183630SPINEART Navigation Instrument SystemJune 10, 2019
K190877Juliet® Ti LL Lumbar Interbody DeviceMay 29, 2019
K190322SCARLET® AC-T Secured Anterior Cervical CageMarch 4, 2019