Medical Device Manufacturer · US , Newport Beach , CA

Orthalign, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 2009

Recent clearances: Packaged Assembly, Reusable Navigation Unit, Lantern® Hip, Harvey(R) Surgical Assistant

15
Total
15
Cleared
0
Denied

Orthalign, Inc. has 15 FDA 510(k) cleared orthopedic devices. Based in Newport Beach, US.

Latest FDA clearance: Jul 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.

15 devices
1-15 of 15
Cleared Jul 31, 2026
Lantern Knee Navigation Unit (406000-03)
K262253 · ONN
Orthopedic · 29d
Cleared Jun 02, 2026
Packaged Assembly, Reusable Navigation Unit
K253507 · ONN
Orthopedic · 211d
Cleared Oct 03, 2024
Lantern® Hip
K242616 · ONN
Orthopedic · 30d
Cleared Jun 18, 2020
Harvey(R) Surgical Assistant
K200892 · OLO
Orthopedic · 76d
Cleared Apr 10, 2020
OrthAlign Plus System
K200642 · OLO
Orthopedic · 30d
Cleared Nov 22, 2017
OrthAlign Plus System
K172462 · OLO
Orthopedic · 100d
Cleared Jul 11, 2017
OrthAlign Plus System
K171780 · OLO
Orthopedic · 26d
Cleared Mar 02, 2017
KneeAlign 2 System
K163379 · OLO
Orthopedic · 91d
Cleared Jan 23, 2017
OrthAlign Plus System
K162962 · OLO
Orthopedic · 91d
Cleared Mar 01, 2016
OrthAlign Plus System
K153237 · OLO
Orthopedic · 113d
Cleared Jun 10, 2014
ORTHALIGN PLUS SYSTEM
K140331 · OLO
Orthopedic · 120d
Cleared Nov 08, 2013
ORTHOALIGN PLUS SYSTEM
K130387 · OLO
Orthopedic · 266d
Cleared Apr 04, 2011
KNEEALIGN SYSTEM
K103829 · OLO
Orthopedic · 95d
Cleared Mar 22, 2010
KNEEALIGN SYSTEM WITH REFERENCE SENSOR
K093998 · OLO
Orthopedic · 84d
Cleared Sep 25, 2009
KNEEALIGN SYSTEM
K091411 · OLO
Orthopedic · 135d
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