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 Prosthesis, Elbow, Hemi-, Radial, Polymer
510(k) Number K233592
Device Name BioPoly Radial Head Implant
Applicant
BioPoly, LLC
7136 Gettysburg Pike
Fort Wayne,  IN  46804
Applicant Contact Herb Schwartz
Correspondent
BioPoly, LLC
7136 Gettysburg Pike
Fort Wayne,  IN  46804
Correspondent Contact Jacob Alumbaugh
Regulation Number888.3170
Classification Product Code
KWI  
Date Received11/08/2023
Decision Date 03/13/2024
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
-
-