Orthalign, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Orthalign, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Packaged Assembly, Reusable Navigation Unit, Lantern® Hip, Harvey(R) Surgical Assistant
14
Total
14
Cleared
0
Denied
Orthalign, Inc. has 14 FDA 510(k) cleared orthopedic devices. Based in Newport Beach, US.
Latest FDA clearance: Jun 2026. Active since 2009.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Orthalign, Inc.
14 devices
Cleared
Jun 02, 2026
Packaged Assembly, Reusable Navigation Unit
Orthopedic
211d
Cleared
Oct 03, 2024
Lantern® Hip
Orthopedic
30d
Cleared
Jun 18, 2020
Harvey(R) Surgical Assistant
Orthopedic
76d
Cleared
Apr 10, 2020
OrthAlign Plus System
Orthopedic
30d
Cleared
Nov 22, 2017
OrthAlign Plus System
Orthopedic
100d
Cleared
Jul 11, 2017
OrthAlign Plus System
Orthopedic
26d
Cleared
Mar 02, 2017
KneeAlign 2 System
Orthopedic
91d
Cleared
Jan 23, 2017
OrthAlign Plus System
Orthopedic
91d
Cleared
Mar 01, 2016
OrthAlign Plus System
Orthopedic
113d
Cleared
Jun 10, 2014
ORTHALIGN PLUS SYSTEM
Orthopedic
120d
Cleared
Nov 08, 2013
ORTHOALIGN PLUS SYSTEM
Orthopedic
266d
Cleared
Apr 04, 2011
KNEEALIGN SYSTEM
Orthopedic
95d
Cleared
Mar 22, 2010
KNEEALIGN SYSTEM WITH REFERENCE SENSOR
Orthopedic
84d
Cleared
Sep 25, 2009
KNEEALIGN SYSTEM
Orthopedic
135d