Medical Device Manufacturer · US , Draper , UT

Ortho Development Corp.

45 submissions · 43 cleared · Since 1996
45
Total
43
Cleared
0
Denied

Ortho Development Corp. — FDA 510(k) Submissions

Ortho Development Corp. has submitted 45 FDA 510(k) premarket notifications since 1996, of which 43 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented, Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented, Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented . Use the specialty filter in the sidebar to narrow results.

45 devices
1–25 of 45
Balanced Knee System TriMax Porous Femoral Components
K253161 · MBH Prosthesis, Knee,... · Orthopedic
Dec 2025 84d
Trivicta? Hip Stem
K251052 · MEH Prosthesis, Hip,... · Orthopedic
May 2025 49d
BKS Revision System
K242984 · JWH Prosthesis, Knee,... · Orthopedic
Oct 2024 29d
Legend? Acetabular Shell
K242833 · LPH Prosthesis, Hip,... · Orthopedic
Oct 2024 22d
Trivicta? Hip Stem
K233758 · MEH Prosthesis, Hip,... · Orthopedic
Mar 2024 105d
IBIS PEDICLE SCREW SYSTEM
K142146 · NKB Thoracolumbosacral... · Orthopedic
Dec 2014 128d
ENCOMPASS 10/12 HIP STEM
K132697 · LPH Prosthesis, Hip,... · Orthopedic
Jun 2014 295d
OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM
K133386 · LPH Prosthesis, Hip,... · Orthopedic
Mar 2014 126d
KASM KNEE ARTICULATING SPACER MOLDS
K133449 · JWH Prosthesis, Knee,... · Orthopedic
Feb 2014 98d
OVATION 10/12 HIP STEM
K131022 · LPH Prosthesis, Hip,... · Orthopedic
Oct 2013 187d
BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA
K131337 · JWH Prosthesis, Knee,... · Orthopedic
Oct 2013 155d
PAGODA PEDICLE SCREW SYSTEM
K131785 · NKB Thoracolumbosacral... · Orthopedic
Aug 2013 63d
VUSION CS PLUS
K122588 · ODP Intervertebral Fusion... · Orthopedic
Jun 2013 292d
BALANCED KNEE SYSTEM HIGH FLEX PS
K123457 · JWH Prosthesis, Knee,... · Orthopedic
Mar 2013 134d
BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT
K090705 · JWH Prosthesis, Knee,... · Orthopedic
Oct 2009 206d
EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES
K062171 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2007 298d
VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
K062666 · MQP Spinal Vertebral Body... · Orthopedic
Jan 2007 140d
EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM
K062775 · LPH Prosthesis, Hip,... · Orthopedic
Jan 2007 120d
ISS INTEGRATED SPINE SYSTEM
K061524 · MNH Orthosis,... · Orthopedic
Sep 2006 116d
BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM
K060569 · JWH Prosthesis, Knee,... · Orthopedic
Jul 2006 125d
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
K060577 · LZO Prosthesis, Hip,... · Orthopedic
Apr 2006 53d
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS
K053587 · LZO Prosthesis, Hip,... · Orthopedic
Mar 2006 84d
ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS
K053293 · LPH Prosthesis, Hip,... · Orthopedic
Feb 2006 83d
ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS
K050637 · JDI Prosthesis, Hip,... · Orthopedic
Sep 2005 196d
LEGEND ALL-POLY CUP
K051407 · JDI Prosthesis, Hip,... · Orthopedic
Sep 2005 100d
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