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 Sacroiliac Joint Fixation
510(k) Number K220195
Device Name iFuse Bedrock Granite™ Implant System
Applicant
SI-BONE, Inc.
471 El Camino Real, Suite 101
Santa Clara,  CA  95050
Applicant Contact Meirav Harsat
Correspondent
SI-BONE, Inc.
471 El Camino Real, Suite 101
Santa Clara,  CA  95050
Correspondent Contact Meirav Harsat
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Codes
NKB   OLO  
Date Received01/24/2022
Decision Date 05/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-