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
510(k) Number K183472
Device Name DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional
Applicant
Synthes (USA) Products LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Fredy Varela
Correspondent
Synthes (USA) Products LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Fredy Varela
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
GAQ  
Date Received12/14/2018
Decision Date 03/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-