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 K113730
Device Name PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS
Applicant
PARCUS MEDICAL, LLC
839 SOUTH NEENAH AVE.
STURGEON BAY,  WI  54235
Applicant Contact PAUL VAGTS
Correspondent
PARCUS MEDICAL, LLC
839 SOUTH NEENAH AVE.
STURGEON BAY,  WI  54235
Correspondent Contact PAUL VAGTS
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received12/19/2011
Decision Date 01/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
-
-