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 K243726
Device Name Osprey Suture Anchor
Applicant
Responsive Arthroscopy, Inc.
701 N. 3rd St.
Suite 208
Minneapolis,  MN  55401
Applicant Contact Gretchen Hinchley
Correspondent
Responsive Arthroscopy, Inc.
701 N. 3rd St.
Suite 208
Minneapolis,  MN  55401
Correspondent Contact Gretchen Hinchley
Regulation Number888.3040
Classification Product Code
MBI  
Date Received12/03/2024
Decision Date 01/30/2025
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
-
-