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 K090923
Device Name PARCUS GRAFT FIXATION SYSTEM
Applicant
Parcus Medical, LLC
839 S. Neenah Ave.
Sturgeon Bay,  WI  54235
Applicant Contact BARTON BRACY
Correspondent
Parcus Medical, LLC
839 S. Neenah Ave.
Sturgeon Bay,  WI  54235
Correspondent Contact BARTON BRACY
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
GAT  
Date Received04/01/2009
Decision Date 06/30/2009
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
-
-