Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Software For Diagnosis/Treatment
510(k) Number K140550
Device Name ORTHOHUB EXTERNAL FIXATOR SOFTWARE
Applicant
Orthohub, Inc.
999 Menlo Oaks Dr.
Menlo Park,  CA  94025
Applicant Contact PEGGY MCLAUGHLIN
Correspondent
Orthohub, Inc.
999 Menlo Oaks Dr.
Menlo Park,  CA  94025
Correspondent Contact PEGGY MCLAUGHLIN
Regulation Number888.3030
Classification Product Code
OSN  
Date Received03/04/2014
Decision Date 08/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-