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 Defect Measurement Tool
510(k) Number K201676
Device Name Barricaid Instrument Tray
Applicant
Intrinsic Therapeutics, Inc.
30 Commerce Way
Woburn,  MA  01801
Applicant Contact Regina Shih
Correspondent
Intrinsic Therapeutics, Inc.
30 Commerce Way
Woburn,  MA  01801
Correspondent Contact Regina Shih
Classification Product Code
QHG  
Date Received06/19/2020
Decision Date 07/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-