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 K133757
Device Name GFS II STANDARD, GFS II LARGE, GFS MIMI
Applicant
Parcus Medical, LLC
6423 Parkland Dr.
Sarasota,  FL  34243
Applicant Contact PAUL VAGTS
Correspondent
Parcus Medical, LLC
6423 Parkland Dr.
Sarasota,  FL  34243
Correspondent Contact PAUL VAGTS
Regulation Number888.3040
Classification Product Code
MBI  
Date Received12/11/2013
Decision Date 02/04/2014
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
-
-