Home / Companies / Orthalign, Inc.

Orthalign, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242616Lantern® HipOctober 3, 2024
K200892Harvey(R) Surgical AssistantJune 18, 2020
K200642OrthAlign Plus SystemApril 10, 2020
K172462OrthAlign Plus SystemNovember 22, 2017
K171780OrthAlign Plus SystemJuly 11, 2017
K163379KneeAlign 2 SystemMarch 2, 2017
K162962OrthAlign Plus SystemJanuary 23, 2017
K153237OrthAlign Plus SystemMarch 1, 2016
K140331ORTHALIGN PLUS SYSTEMJune 10, 2014
K130387ORTHOALIGN PLUS SYSTEMNovember 8, 2013
K103829KNEEALIGN SYSTEMApril 4, 2011
K093998KNEEALIGN SYSTEM WITH REFERENCE SENSORMarch 22, 2010
K091411KNEEALIGN SYSTEMSeptember 25, 2009