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 mesh, surgical, polymeric
510(k) Number K230671
Device Name Pitch PaSoft Tissue Reinforcement Device
Applicant
Xiros Ltd
Springfield House Lane, Whitehouse Lane
Leeds,  GB LS17 7UE
Applicant Contact Steve Curran
Correspondent
Xiros Inc
20 Cabot Blvd., Suite 300
Mansfield,  MA  02448
Correspondent Contact John Mahoney
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
OWX  
Date Received03/10/2023
Decision Date 05/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-