Medical Device Manufacturer · US , Bartlett , TN

Shanghai Sanyou Medical Co, Ltd. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2013

Recent clearances: Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System, Zeus Spinal System, Adena-Zina Spinal System

9
Total
9
Cleared
0
Denied

FDA 510(k) Regulatory Record - Shanghai Sanyou Medical Co, Ltd. Orthopedic ✕

9 devices
1-9 of 9
Cleared Dec 12, 2023
Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™...
K230872 · MAX
Orthopedic · 257d
Cleared Oct 10, 2023
Zeus Spinal System
K230961 · NKB
Orthopedic · 188d
Cleared Jul 28, 2023
Adena-Zina Spinal System
K231931 · NKB
Orthopedic · 28d
Cleared Sep 21, 2021
KEYSTONE PEEK Cage System
K211689 · MAX
Orthopedic · 111d
Cleared Aug 16, 2021
Adena-Zina System
K212066 · NKB
Orthopedic · 45d
Cleared Oct 05, 2017
Shanghai Sanyou CARMEN Cervical Fusion System
K163366 · KWQ
Orthopedic · 309d
Cleared Sep 18, 2017
Shanghai Sanyou PEEK Cage System
K163422 · ODP
Orthopedic · 286d
Cleared Feb 12, 2016
Adena-Zina System
K152781 · NKB
Orthopedic · 140d
Cleared Aug 07, 2013
KATIA SYSTEM
K131512 · KWQ
Orthopedic · 71d
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