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 Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K222589
Device Name Flexible Suturing System with Anchors (FSSA)
Applicant
Integrity Orthopaedics, Inc.
5565 Pioneer Creek Dr.
Maple Plain,  MN  55359
Applicant Contact Jeff Sims
Correspondent
Integrity Orthopaedics, Inc.
5565 Pioneer Creek Dr.
Maple Plain,  MN  55359
Correspondent Contact Jeff Sims
Regulation Number888.3040
Classification Product Code
MBI  
Date Received08/26/2022
Decision Date 01/26/2023
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
-
-