Spineart is one of 92 FDA 510(k) medical device manufacturers from Switzerland in the dataset, ranked by real submission volume.
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
Spineart has 44 FDA 510(k) cleared orthopedic devices. Based in Geneva, CH.
Last cleared in 2023. Active since 2008.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mcra, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Spineart
44 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
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