Spineart SA - FDA 510(k) Cleared Devices
Recent clearances: SCALA® TL, BAGUERA® C Cervical Disc Surgical Instruments, SPINEART Navigation Instrument System
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spineart SA Orthopedic ✕
14 devices
Cleared
Aug 20, 2026
SCALA® TL
Orthopedic
142d
Cleared
Aug 14, 2026
BAGUERA® C Cervical Disc Surgical Instruments
Orthopedic
16d
Cleared
Jul 29, 2026
SPINEART Navigation Instrument System
Orthopedic
107d
Cleared
May 01, 2026
PERLA® TL Posterior Thoraco-lumbar Fixation System
Orthopedic
141d
Cleared
Apr 09, 2026
SPINEART Navigation Instrument System
Orthopedic
108d
Cleared
Jun 18, 2025
SPINEART Navigation Instrument System
Orthopedic
266d
Cleared
Mar 07, 2025
SPINEART Navigation Instrument System
Orthopedic
165d
Cleared
Oct 23, 2024
Scarlet® AL-T
Orthopedic
54d
Cleared
Aug 07, 2024
SPINEART Navigation Instrument System
Orthopedic
61d
Cleared
Jul 18, 2024
Juliet® Ti LL Lumbar Interbody Device
Orthopedic
69d
Cleared
May 10, 2024
SCARLET® AC-Ti
Orthopedic
57d
Cleared
Oct 25, 2023
PERLA® TL Posterior Thoraco-lumbar Fixation System
Orthopedic
194d
Cleared
Mar 22, 2023
Tryptik Ti
Orthopedic
20d
Cleared
Jun 10, 2019
SPINEART Navigation Instrument System
Orthopedic
166d