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 Screw, Fixation, Bone
510(k) Number K012280
Device Name TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2
Applicant
Triage Medical, Inc.
3722 Ave. Sausalito
Irvine,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
Triage Medical, Inc.
3722 Ave. Sausalito
Irvine,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/19/2001
Decision Date 08/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-