United Orthopedic Corporation is one of 203 FDA 510(k) medical device manufacturers from Taiwan in the dataset, ranked by real submission volume.
United Orthopedic Corporation - FDA 510(k) Cleared Devices
Recent clearances: Stem Extension Line (U2 Total Knee System—PSA Type), Stem Extension Line (USTAR II System), U2 Total Knee System – PF+ Patella
40
Total
40
Cleared
0
Denied
United Orthopedic Corporation has 40 FDA 510(k) cleared orthopedic devices. Based in Hsinchu, TW.
Latest FDA clearance: Sep 2025. Active since 2011.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by NJK & Associates, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - United Orthopedic Corporation
40 devices
Cleared
Sep 25, 2025
Stem Extension Line (U2 Total Knee System—PSA Type)
Orthopedic
28d
Cleared
Aug 22, 2025
Stem Extension Line (USTAR II System)
Orthopedic
29d
Cleared
Jul 31, 2025
U2 Total Knee System – PF+ Patella
Orthopedic
247d
Cleared
May 01, 2025
Resolve Modular Revision Hip Stem
Orthopedic
269d
Cleared
Jan 06, 2025
Conformity Stem Extension Line, #0
Orthopedic
59d
Cleared
Dec 20, 2024
Cellbrick Knee Spacer
Orthopedic
84d
Cleared
Aug 30, 2024
Conformity Stem Extension Line
Orthopedic
30d
Cleared
Feb 28, 2023
U2 Total Knee System-PF+
Orthopedic
260d
Cleared
Jan 05, 2023
U-Motion II Acetabular System-Extension line
Orthopedic
260d
Cleared
Nov 04, 2022
United U2 femoral head, 22mm delta ceramic head
Orthopedic
148d
Cleared
Oct 06, 2022
Tibial baseplate, Tibial insert
Orthopedic
29d
Cleared
Apr 21, 2021
U2 Total Knee System, XPE Tibial Insert, PS PLUS
Orthopedic
21d
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