Medical Device Manufacturer · US , Draper , UT

Ortho Development Corporation - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2015

Recent clearances: Balanced Knee® System TriMax PS Plus Tibial Insert, The Progen™ Trochanteric Nail System, Balanced Knee System Uni

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ortho Development Corporation Orthopedic ✕

14 devices

1-12 of 14

Cleared Oct 25, 2023

Balanced Knee® System TriMax PS Plus Tibial Insert

Orthopedic · 29d

Cleared Dec 21, 2021

The Progen™ Trochanteric Nail System

Orthopedic · 253d

Cleared Dec 16, 2021

Balanced Knee System Uni

Orthopedic · 219d

Cleared Jul 14, 2021

Pisces Spinal System

Orthopedic · 285d

Cleared Mar 31, 2020

The Gecko Spinal System

Orthopedic · 56d

Cleared Oct 31, 2018

Balanced Knee Revision System Trabecular Tibial Cone Augments

Orthopedic · 90d

Cleared Oct 12, 2018

BKS Revision Sleeves System

Orthopedic · 120d

Cleared Jun 20, 2018

Balanced Knee Revision System - Offset Junction Box

Orthopedic · 90d

Cleared May 30, 2018

Legend Acetabular Liners

Orthopedic · 154d

Cleared Aug 24, 2017

Entrada™ hip stem

Orthopedic · 118d

Cleared Mar 30, 2017

Ibis® Pedicle Screw System

Orthopedic · 154d

Cleared May 17, 2016

Escalade Legend Acetabular Shell

Orthopedic · 29d