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, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
510(k) Number K202716
Device Name Ignite Anatomic Shoulder System
Applicant
Ignite Orthopedics, LLC
700 Park Ave.
Suite F
Winona Lake,  IN  46590
Applicant Contact Matt Purdy
Correspondent
Ignite Orthopedics, LLC
700 Park Ave.
Suite F
Winona Lake,  IN  46590
Correspondent Contact Russ Parrott
Regulation Number888.3670
Classification Product Code
MBF  
Subsequent Product Codes
HSD   KWS   KWT   PAO  
Date Received09/17/2020
Decision Date 05/20/2021
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
-
-