Spineart - FDA 510(k) Cleared Devices
Recent clearances: PERLA® TL System, PERLA® TL Posterior Osteosynthesis System, SPINEART Navigation Instrument System
44
Total
44
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spineart Orthopedic ✕
43 devices
Cleared
Jun 23, 2023
PERLA® TL System
Orthopedic
94d
Cleared
Jan 21, 2022
PERLA® TL Posterior Osteosynthesis System
Orthopedic
85d
Cleared
Mar 19, 2021
SPINEART Navigation Instrument System
Orthopedic
30d
Cleared
Jan 15, 2021
PERLA® TL posterior osteosynthesis system
Orthopedic
46d
Cleared
Dec 17, 2020
PERLA TL Posterior Osteosynthesis System
Orthopedic
45d
Cleared
May 01, 2020
PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
Orthopedic
58d
Cleared
Apr 06, 2020
Tryptik Ti
Orthopedic
60d
Cleared
Feb 05, 2020
PERLA® TL posterior osteosynthesis system
Orthopedic
61d
Cleared
Jan 22, 2020
SCARLET AL-T
Orthopedic
89d
Cleared
May 29, 2019
Juliet® Ti LL Lumbar Interbody Device
Orthopedic
55d
Cleared
Mar 04, 2019
SCARLET® AC-T Secured Anterior Cervical Cage
Orthopedic
19d
Cleared
Feb 25, 2019
Perla® Posterior Cervico-Thoracic Fixation System
Orthopedic
41d
Looking for a specific device from Spineart? Search by device name or K-number.
Search all Spineart devices