Medical Device Manufacturer · CA , Montreal

Orthosoft Inc. (d/b/a) Zimmer CAS - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2017

Recent clearances: Signature™ ONE System, ROSA® Shoulder System, Signature™ ONE System

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20
Total
20
Cleared
0
Denied

FDA 510(k) Regulatory Record - Orthosoft Inc. (d/b/a) Zimmer CAS Orthopedic ✕

18 devices
1-12 of 18
Cleared Jun 04, 2026
Signature™ ONE System
K261510 · QHE
Orthopedic · 28d
Cleared May 21, 2026
ROSA® Shoulder System
K260582 · OLO
Orthopedic · 90d
Cleared Feb 04, 2026
Signature™ ONE System
K260104 · QHE
Orthopedic · 22d
Cleared Nov 13, 2025
Rosa® Knee System
K251314 · OLO
Orthopedic · 199d
Cleared Oct 18, 2024
ROSA® Knee System
K242864 · OLO
Orthopedic · 28d
Cleared Feb 21, 2024
ROSA® Shoulder System
K233199 · OLO
Orthopedic · 146d
Cleared Dec 12, 2023
Signature™ ONE System
K232425 · QHE
Orthopedic · 123d
Cleared Jun 13, 2023
OptiVu™ ROSA® MxR
K230567 · SBF
Orthopedic · 104d
Cleared Feb 22, 2023
Rosa Knee System
K230180 · OLO
Orthopedic · 30d
Cleared Jul 29, 2022
OptiVu ROSA MxR
K220733 · SBF
Orthopedic · 137d
Cleared Apr 22, 2022
ROSA® Knee System
K213708 · OLO
Orthopedic · 149d
Cleared Oct 12, 2021
Signature™ ONE System
K212560 · QHE
Orthopedic · 60d
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