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 Plate, Fixation, Bone
510(k) Number K241282
Device Name RibFix Titan™ Fixation System
Applicant
Riverpoint Medical
825 NE 25th Ave.
Portland,  OR  97232
Applicant Contact Paul Vagts
Correspondent
Riverpoint Medical
825 NE 25th Ave.
Portland,  OR  97232
Correspondent Contact Paul Vagts
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HTN  
Date Received05/07/2024
Decision Date 08/19/2024
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
-
-