Medical Device Manufacturer · CH , Plan-Les-Ouates

Spineart SA - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2019

Recent clearances: PERLA® TL Posterior Thoraco-lumbar Fixation System, SPINEART Navigation Instrument System, SPINEART Navigation Instrument System

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11
Total
11
Cleared
0
Denied

FDA 510(k) Regulatory Record - Spineart SA Orthopedic ✕

11 devices
1-11 of 11
Cleared May 01, 2026
PERLA® TL Posterior Thoraco-lumbar Fixation System
K253966 · NKB
Orthopedic · 141d
Cleared Apr 09, 2026
SPINEART Navigation Instrument System
K254158 · OLO
Orthopedic · 108d
Cleared Jun 18, 2025
SPINEART Navigation Instrument System
K242933 · OLO
Orthopedic · 266d
Cleared Mar 07, 2025
SPINEART Navigation Instrument System
K242890 · OLO
Orthopedic · 165d
Cleared Oct 23, 2024
Scarlet® AL-T
K242589 · MAX
Orthopedic · 54d
Cleared Aug 07, 2024
SPINEART Navigation Instrument System
K241644 · OLO
Orthopedic · 61d
Cleared Jul 18, 2024
Juliet® Ti LL Lumbar Interbody Device
K241321 · OVD
Orthopedic · 69d
Cleared May 10, 2024
SCARLET® AC-Ti
K240699 · OVE
Orthopedic · 57d
Cleared Oct 25, 2023
PERLA® TL Posterior Thoraco-lumbar Fixation System
K231069 · NKB
Orthopedic · 194d
Cleared Mar 22, 2023
Tryptik Ti
K230583 · ODP
Orthopedic · 20d
Cleared Jun 10, 2019
SPINEART Navigation Instrument System
K183630 · OLO
Orthopedic · 166d
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