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 Rongeur, Manual
510(k) Number K230256
Device Name Rebellion, Phantom Multi-Bite Kerrison Rongeur
Applicant
Morpheus AG
Bahnhofstraße 18
Spaichingen,  DE 78549
Applicant Contact Dimitri Krutsch
Correspondent
Morpheus AG
Bahnhofstraße 18
Spaichingen,  DE 78549
Correspondent Contact Dimitri Krutsch
Regulation Number882.4840
Classification Product Code
HAE  
Date Received01/31/2023
Decision Date 03/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-