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

FDA 510(k) Regulatory Record - Orthalign, Inc. Orthopedic ✕

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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