Medical Device Manufacturer · FR , Ecully

Spineway - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2015
5
Total
5
Cleared
0
Denied

Spineway has 5 FDA 510(k) cleared medical devices. Based in Ecully, FR.

Last cleared in 2023. Active since 2015. Primary specialty: Orthopedic.

Browse the FDA 510(k) cleared devices submitted by Spineway Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by The OrthoMedix Group, Inc. as regulatory consultant.

FDA 510(k) Regulatory Record - Spineway
5 devices
1-5 of 5
Cleared Oct 10, 2023
VEOS Spinal Fixation System
K231658 · NKB
Orthopedic · 125d
Cleared Jan 12, 2017
Ayers Rock Cervical interbody fusion system
K162694 · ODP
Orthopedic · 107d
Cleared Dec 10, 2015
Twin Peaks Lumbar Interbody Fusion System
K152355 · MAX
Orthopedic · 112d
Cleared May 12, 2015
Mont Blanc Spinal System
K150185 · NKB
Orthopedic · 105d
Cleared May 07, 2015
Blue Mountain Cervical Plate System
K150036 · KWQ
Orthopedic · 118d
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