Medical Device Manufacturer · FR , Valence

Amplitude - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2017
2
Total
2
Cleared
0
Denied

Amplitude has 2 FDA 510(k) cleared medical devices. Based in Valence, FR.

Last cleared in 2023. Active since 2017. Primary specialty: Orthopedic.

Browse the FDA 510(k) cleared devices submitted by Amplitude 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 - Amplitude
2 devices
1-2 of 2
Cleared Nov 03, 2023
TRAX® CR Total Knee System
K230078 · JWH
Orthopedic · 297d
Cleared Jan 19, 2017
Anatomic Total Knee System
K161414 · JWH
Orthopedic · 241d
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