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 staple, fixation, bone
510(k) Number K063273
Device Name PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR
Applicant
DEPUY MILTEK, A JOHNSON & JOHNSON CO.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Applicant Contact KRISTINE CHRISTO
Correspondent
DEPUY MILTEK, A JOHNSON & JOHNSON CO.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Correspondent Contact KRISTINE CHRISTO
Regulation Number888.3030
Classification Product Code
JDR  
Subsequent Product Code
MAI  
Date Received10/30/2006
Decision Date 11/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-