Medical Device Manufacturer · US , Draper , UT

Ortho Development Corporation

14 submissions · 14 cleared · Since 2015
14
Total
14
Cleared
0
Denied

Ortho Development Corporation — FDA 510(k) Submissions

Ortho Development Corporation has submitted 14 FDA 510(k) premarket notifications since 2015, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented, Thoracolumbosacral Pedicle Screw System, Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented, Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
Balanced Knee? System TriMax PS Plus Tibial Insert
K233093 · JWH Prosthesis, Knee,... · Orthopedic
Oct 2023 29d
The Progen? Trochanteric Nail System
K211086 · HSB Rod, Fixation,... · Orthopedic
Dec 2021 253d
Balanced Knee System Uni
K211471 · HSX Prosthesis, Knee,... · Orthopedic
Dec 2021 219d
Pisces Spinal System
K203023 · NKB Thoracolumbosacral... · Orthopedic
Jul 2021 285d
The Gecko Spinal System
K200281 · OWI Bone Fixation Cerclage,... · Orthopedic
Mar 2020 56d
Balanced Knee Revision System Trabecular Tibial Cone Augments
K182085 · JWH Prosthesis, Knee,... · Orthopedic
Oct 2018 90d
BKS Revision Sleeves System
K181569 · JWH Prosthesis, Knee,... · Orthopedic
Oct 2018 120d
Balanced Knee Revision System - Offset Junction Box
K180743 · JWH Prosthesis, Knee,... · Orthopedic
Jun 2018 90d
Legend Acetabular Liners
K173951 · LPH Prosthesis, Hip,... · Orthopedic
May 2018 154d
Entrada? hip stem
K171249 · MEH Prosthesis, Hip,... · Orthopedic
Aug 2017 118d
Ibis? Pedicle Screw System
K162995 · NKB Thoracolumbosacral... · Orthopedic
Mar 2017 154d
Escalade Legend Acetabular Shell
K161080 · LPH Prosthesis, Hip,... · Orthopedic
May 2016 29d
Alpine Cemented Hip System
K153216 · JDI Prosthesis, Hip,... · Orthopedic
Feb 2016 105d
Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts
K152169 · JWH Prosthesis, Knee,... · Orthopedic
Oct 2015 84d
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