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, biodegradable, soft tissue
510(k) Number K150209
Device Name Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAncho
Applicant
Depuy Mitek, a Johnson and Johnson Company
325 Paramount Drive
Raynham,  MA  02767
Applicant Contact YAYOI FUJIMAKI
Correspondent
Depuy Mitek, a Johnson and Johnson Company
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact YAYOI FUJIMAKI
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Codes
HTY   JDR   MBI  
Date Received01/30/2015
Decision Date 10/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-