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 Orthopedic Stereotaxic Instrument
510(k) Number K232140
Device Name OTS Hip
Applicant
Ortoma AB
Falkenbergsgatan 3
Gothenburg,  SE 412 85
Applicant Contact Linus Byström
Correspondent
Hogan Lovells, LLC
Columbia Square, 555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/18/2023
Decision Date 03/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-